Investigação de Segurança, Tolerabilidade e Farmacocinética (PK) de GSK3494245 em Participantes Saudáveis
8 de abril de 2026 atualizado por: GlaxoSmithKline
Um estudo randomizado, duplo-cego, controlado por placebo, realizado pela primeira vez em humanos para avaliar a segurança, tolerabilidade e farmacocinética de doses únicas (nos estados alimentado e em jejum) de GSK3494245 em participantes saudáveis
Este é um estudo de Fase 1, duplo-cego, randomizado, controlado por placebo, pela primeira vez em humanos (FTIH) para avaliar a segurança, tolerabilidade e farmacocinética de uma dose única de GSK3494245.
O estudo será composto por 3 coortes, conduzidas de forma sequencial.
As coortes 1 e 2 consistirão em uma única dose ascendente (SAD), design cruzado em que cada participante receberá no máximo 3 doses orais ascendentes de GSK3494245 e 1 dose de placebo em condições de jejum.
Em cada nível de dosagem, GSK3494245 e placebo serão administrados na proporção de 3:1, dentro de cada período, de acordo com o cronograma de randomização de forma cega.
A Coorte 3 compreenderá um cruzamento de 2 vias que inclui 1 regime de dosagem em condições de jejum e alimentação e 1 regime em condições de alimentação e jejum em uma proporção de 1:1.
As condições de alimentação investigarão o efeito da segurança, tolerabilidade e PK de uma dose única de GSK3494245 após a administração de alimentos.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
The study originally planned to include 2 parts - a single ascending doses (SAD) part and a multiple ascending doses (MAD) part, incorporating a food effect component to investigate the influence of food on the PK of GSK3494245.
However, only the SAD part was conducted due to a decision to terminate the study early.
Tipo de estudo
Intervencional
Inscrição (Real)
59
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Cambridge, Reino Unido, CB2 2GG
- GSK Investigational Site
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Descrição
Critério de inclusão
- O participante deve ter entre 18 e <= 50 anos de idade, no momento da assinatura do consentimento informado.
- O participante deve ser saudável conforme determinado pelo investigador ou seu representante médico qualificado com base em uma avaliação médica, incluindo histórico médico, exame físico, exames laboratoriais e monitoramento cardíaco. Um participante com uma anormalidade clínica ou parâmetro(s) laboratorial(is) que esteja/não esteja especificamente listado nos critérios de inclusão ou exclusão, fora do intervalo de referência normal para a população em estudo, poderá ser incluído apenas se o Investigador em consulta com o Monitor Médico ( se necessário) concordar e documentar que é improvável que o achado introduza fatores de risco adicionais e não interfira nos procedimentos do estudo.
- Peso corporal >=50 kg (kg) e índice de massa corporal (IMC) na faixa de 18,5-28 kg por metro quadrado (kg/m^2) (inclusive).
- Apenas participantes do sexo masculino. Um participante do sexo masculino com uma parceira com potencial reprodutivo deve concordar em usar contracepção durante o período de intervenção e por pelo menos 90 dias após a última dose do tratamento do estudo e abster-se de doar esperma durante esse período.
- Capaz de dar consentimento informado assinado, que inclui o cumprimento dos requisitos e restrições listados no formulário de consentimento informado (TCLE) e protocolo.
Critério de exclusão
- História ou presença de distúrbios cardiovasculares, respiratórios, hepáticos, renais, gastrointestinais, endócrinos, hematológicos ou neurológicos capazes de alterar significativamente a absorção, metabolismo ou eliminação de drogas; constituir um risco ao fazer o tratamento do estudo; ou interferir na interpretação dos dados.
- Pressão arterial anormal, conforme determinado pelo investigador.
- História pregressa de leishmaniose.
- Alanina aminotransferase (ALT) maior que 1,5 vez o limite superior do normal (LSN).
- Bilirrubina total superior a 1,5 vezes o LSN (bilirrubina isolada superior a 1,5 vezes o LSN é aceitável se a bilirrubina total for fracionada e a bilirrubina direta inferior a 35 por cento [%]).
- História atual ou crônica de doença hepática ou anormalidades hepáticas ou biliares conhecidas (com exceção da síndrome de Gilbert ou cálculos biliares assintomáticos).
- Atual ou história de gastrite clinicamente significativa ou úlceras gastroduodenais ou uso regular de anti-inflamatórios não esteróides (AINE).
- Consumo de mais de 14 unidades/semana de álcool (voluntários do sexo masculino).
- Atual ou história de alteração no paladar ou olfato sem qualquer explicação clínica plausível com base no julgamento clínico do investigador.
- QTc superior a 450 milissegundos (mseg) com base na média de ECGs triplicados.
- Anormalidades na forma de onda, incluindo trigêmeos de contração ventricular prematura (PVC) e mais de 500 PVCs únicos em 24 horas, ou qualquer outra anormalidade a critério do investigador.
- História médica de arritmias cardíacas ou doença cardíaca ou história familiar ou pessoal de síndrome do QT longo.
- Uso passado ou pretendido de medicamentos de venda livre ou prescritos, incluindo medicamentos fitoterápicos, AINEs, inibidores da bomba de prótons (IBPs) ou antagonistas do receptor anti-histamínico 2 (H2) dentro de 7 dias (ou 14 dias se o medicamento for uma enzima potencial indutor) ou 5 meias-vidas (a que for mais longa) antes da dosagem. Outra medicação concomitante pode ser considerada caso a caso pelo investigador em consulta com o monitor médico. O paracetamol é permitido (limitado a <= 2 gramas/dia).
- Participação no estudo que resultaria em perda de sangue ou hemoderivados superior a 500 mililitros (mL) em um período de 56 dias.
- Exposição a mais de 4 novas entidades químicas dentro de 12 meses antes do primeiro dia de dosagem.
- Inscrição atual ou participação anterior nos últimos 30 dias antes da assinatura do consentimento em qualquer outro estudo clínico envolvendo uma intervenção de estudo investigacional ou qualquer outro tipo de pesquisa médica.
- Inscrição atual ou participação anterior neste estudo clínico.
- Participantes com função renal definida como Crônica Kidney Disease Epidemiology Collaboration (CKD-EPI) com uma taxa de filtração glomerular apropriada para a idade (GFR) <90 (mililitro por minuto por 1,73 metros quadrados [mL/min/1,73m^2]).
- Triagem da relação albumina:creatinina na urina >30 miligramas por grama (mg/g) (>3 miligramas por milimole [mg/mmol])
- Presença do resultado do teste do antígeno de superfície da hepatite B (HBsAg) na triagem.
- Resultado positivo do teste de anticorpo para hepatite C na triagem.
- Resultado positivo do teste de ácido ribonucleico (RNA) para hepatite C na triagem.
- Teste de anticorpo positivo para o vírus da imunodeficiência humana (HIV).
- Presença de hematúria e/ou proteinúria clinicamente significativas.
- Níveis de monóxido de carbono indicativos de tabagismo ou história ou uso regular de tabaco ou produtos que contenham nicotina dentro de 3 meses antes da triagem.
- Teste positivo de drogas/álcool pré-estudo.
- Uso regular de drogas de abuso conhecidas.
- Food Effect Coorte 3 apenas: O participante não deve ter restrições alimentares (por exemplo, intolerância à lactose) ou incapacidade de comer gelatina ou uma refeição padrão adaptada (inclui 35-40% de teor de gordura).
- Food Effect Coorte 3 apenas: História de cirurgia de vesícula biliar ou remoção de vesícula biliar, ou história de um estado de doença aguda (por exemplo, colelitíase) dentro de 14 dias antes de receber o tratamento do estudo.
- Os participantes não devem ter viajado para uma área (conforme determinado pelo investigador) com alta prevalência de infecções leishmaniose/parasitárias nos 6 meses anteriores à triagem ou pretender fazê-lo nos 3 meses após a dose final do tratamento do estudo.
- Sensibilidade a qualquer um dos tratamentos do estudo, ou seus componentes, ou alergia a medicamentos ou outras alergias que, na opinião do Investigador ou do Monitor Médico da GSK, contra-indicam a participação no estudo.
- Uma confirmação laboratorial positiva de infecção por doença do vírus corona 2019 (COVID-19) ou alto índice clínico de suspeita de COVID-19.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Cohort 1 Treatment Sequence (Seq) 1: GSK3494245 20 milligram (mg) fasted/Placebo (PBO)
Participants received 20 mg of GSK3494245 during dosing period 1 and Placebo matching the active dose amount during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 1 Treatment Seq 2: PBO/GSK3494245 40mg fasted
Participants received Placebo during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 1 Treatment Seq 3: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimental: Cohort 1 Treatment Seq 4: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimental: Cohort 2 Treatment Seq 1:GSK3494245 40mg fasted/GSK3494245 80mg fasted/GSK3494245 120mg fasted/PBO
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and matching Placebo during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 2 Treatment Seq 2:GSK3494245 40mg fasted/GSK3494245 80mg fasted/PBO/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, matching placebo during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 2 Treatment Seq 3:GSK3494245 40mg fasted/PBO/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, matching placebo during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 2 Treatment Seq 4: PBO/GSK3494245 80mg fasted/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received placebo during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 2A Treatment Seq 1: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimental: Cohort 2A Treatment Seq 2: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimental: Cohort 2A Treatment Seq 3: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimental: Cohort 2A Treatment Seq 4: PBO fasted
Participants received Placebo during dosing period 1 under fasted conditions, at Day 1.
|
Matching placebo capsules were provided
|
|
Experimental: Cohort 3 Treatment Seq 1: PBO fed/PBO fasted/GSK3494245 80mg fasted/GSK3494245 80mg fed
Participants received Placebo in fed conditions during dosing period 1, Placebo in fasted conditions during dosing period 2, 80 mg of GSK3494245 in fasted conditions during dosing period 3 and 80 mg of GSK3494245 in fed conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 3 Treatment Seq 2: PBO fasted/GSK3494245 80mg fed/PBO fed/GSK3494245 80mg fasted
Participants received Placebo in fasted conditions during dosing period 1, 80 mg of GSK3494245 in fed conditions during dosing period 2, placebo in fed conditions during dosing period 3 and 80 mg of GSK3494245 in fasted conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 3 Treatment Seq 3: GSK3494245 80mg fed/GSK3494245 80mg fasted/PBO fasted/PBO fed
Participants received 80 mg of GSK3494245 in fed conditions during dosing period 1, 80 mg of GSK3494245 in fasted conditions during dosing period 2, Placebo in fasted conditions during dosing period 3 and placebo in fed conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 3 Treatment Seq 4: GSK3494245 80mg fasted/PBO fed/GSK3494245 80mg fed/PBO fasted
Participants received 80 mg of GSK3494245 in fasted conditions during dosing period 1, Placebo in fed conditions during dosing period 2, 80 mg of GSK3494245 in fed conditions during dosing period 3 and placebo in fasted conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 3A Treatment Seq 1: PBO fed/GSK3494245 240mg fed
Participants received placebo in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 3A Treatment Seq 2: GSK3494245 160mg fed/PBO fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and Placebo in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
Experimental: Cohort 3A Treatment Seq 3: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
Experimental: Cohort 3A Treatment Seq 4: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Prazo: From Day 1 (first dose) up to 14 days post last dose in each treatment period
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
|
From Day 1 (first dose) up to 14 days post last dose in each treatment period
|
|
Number of Participants With Serious Adverse Events (SAEs)
Prazo: From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
|
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
|
From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
|
|
Number of Participants With Treatment Emergent AEs (TEAEs) and Treatment Emergent SAEs
Prazo: From Day 1 (first dose) up to 2 days post last dose in each treatment period
|
A TEAE and treatment emergent SAE is considered any untoward medical occurrence in a clinical study participant, considered by the investigator to have a causal relationship with study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
From Day 1 (first dose) up to 2 days post last dose in each treatment period
|
|
Summary of Change From Baseline in Hematology Parameters: Basophils, Neutrophils, Eosinophils, Lymphocytes, Monocytes and Platelets
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: basophils, neutrophils, eosinophils, lymphocytes, monocytes and platelets.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
Standard deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Volume
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular volume.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular hemoglobin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Erythrocytes and Reticulocytes
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: erythrocytes and reticulocytes.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Hemoglobin
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: hemoglobin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Hematocrit and Reticulocytes
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: hematocrit and reticulocytes.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT)
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: ALT, ALP, AST, CPK, and GGT.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Albumin, Protein
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: albumin and protein.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Calcium Corrected for Albumin, Glucose, Lactic Acid, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, and Urea
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for clinical chemistry parameters: bicarbonate, calcium corrected for albumin, glucose, lactic acid, magnesium, phosphate, potassium, sodium, triglycerides, urea.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
Generally, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments on Day 1 lacked timing, the first recorded was used.
If one Day 1 assessment lacked timing, the last available from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, Baseline was set to missing.
Change from baseline is defined as post-dose value minus baseline value.
SD=0.0000 indicates SD below the detectable assay limit, approximated to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: bilirubin, creatinine, direct bilirubin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: C-reactive Protein (CRP)
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: CRP.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: pH
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: pH.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Number of Participants With Worst-case Urinalysis Results
Prazo: From Day 1 up to 14 Days post last dose
|
Urine samples were collected for the assessment of urinalysis parameters, which include pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
|
From Day 1 up to 14 Days post last dose
|
|
Summary of Change From Baseline in Physical Examinations: Body Mass Index (BMI)
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Vital Signs: Respiratory Rate
Prazo: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Supine Diastolic Blood Pressure, Supine Systolic Blood Pressure
Prazo: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Supine Pulse Rate
Prazo: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Tympanic Membrane Temperature
Prazo: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Physical Examinations: Weight
Prazo: At Day 2 and Day 4 in each treatment period compared to Baseline
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Electrocardiogram (ECG) Parameters: Heart Rate
Prazo: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, Corrected QT (QTc) Interval, QT Interval Corrected Using Bazett's Formula, QT Interval Corrected, Using Fridericia's Formula
Prazo: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured the PR interval, QRS interval, QT interval, and QTc interval.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Number of Participants With Abnormal Cardiac Telemetry Findings
Prazo: Up to 24 hours post first dose on Day 1
|
Telemetry is defined as the continuous monitoring of a participant's heart rate and rhythm from a remote location.
|
Up to 24 hours post first dose on Day 1
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve (AUC[0-t]) of GSK3494245 Following Single Dose Administration, Under Fasting Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC (0-t) of GSK3494245 Following Single Dose Administration Under Fed Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC-time Curve From Time Zero to Extrapolated to Infinity (AUC[0-inf]) of GSK3494245 Following Single Dose Administration Under Fasting Condition
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC (0-inf) of GSK3494245 Following Single Dose Administration Under Fed Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Maximum Observed Plasma Drug Concentration (Cmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Cmax is defined as the maximum concentration of the drug in plasma.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Cmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Cmax is defined as the maximum concentration of the drug in plasma.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Tmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Apparent Terminal Half-life (t1/2) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
t1/2 of GSK3494245 Following Single Dose Administration Under Fed Conditions
Prazo: At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Dose-proportionality Assessment Using AUC(0-inf) Following a Single Dose of GSK3494245
Prazo: At Day 1 (post-dose)
|
A power model was used to assess the dose proportionality.
A slope of 1 indicates that PK increased linearly with the dose.
A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
|
At Day 1 (post-dose)
|
|
Dose-proportionality Assessment Using Cmax Following Single Dose of GSK3494245
Prazo: At Day 1 (post-dose)
|
A power model was used to assess the dose proportionality.
A slope of 1 indicates that PK increased linearly with the dose.
A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
|
At Day 1 (post-dose)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de setembro de 2020
Conclusão Primária (Real)
14 de janeiro de 2024
Conclusão do estudo (Real)
14 de janeiro de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
5 de agosto de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2020
Primeira postagem (Real)
7 de agosto de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 208441
- 2019-004492-39 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
O IPD para este estudo será disponibilizado através do site Clinical Study Data Request.
Prazo de Compartilhamento de IPD
O IPD será disponibilizado dentro de 6 meses após a publicação dos resultados dos parâmetros primários, principais parâmetros secundários e dados de segurança do estudo.
Critérios de acesso de compartilhamento IPD
O acesso é fornecido depois que uma proposta de pesquisa é enviada e aprovada pelo Painel de Revisão Independente e depois que um Acordo de Compartilhamento de Dados está em vigor.
O acesso é concedido por um período inicial de 12 meses, podendo ser prorrogado, quando justificado, por mais 12 meses.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .