A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
29 de novembro de 2017 atualizado por: Achaogen, Inc.
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and the Drug-Drug Interaction Potential of Oral ACHN-383 and ACHN-789 in Healthy Subjects
This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
40
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
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Perth, Austrália
- Clinical Site
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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 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Key Inclusion Criteria:
- Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug
- Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile
- Body mass index (BMI) of ≥19 kg/m^2 to ≤32 kg/m^2 and weight ≥50 kg to ≤125 kg
- Normal renal function as determined by creatinine clearance (CLcr) rate
Key Exclusion Criteria:
- Pregnant women
- History of any hepatic or biliary disorder or disease
- Any condition that could possibly affect oral drug absorption
- Unstable cardiovascular disease
- Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
- HIV positive
- Active malignancy
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 Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cohort 1
Healthy volunteers
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Dose oral
Oral dose
Oral dose
|
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Experimental: Cohort 2
Healthy volunteers
|
Dose oral
Oral dose
Oral dose
|
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Experimental: Cohort 3
Healthy volunteers
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Dose oral
Oral dose
Oral dose
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Experimental: Cohort 4
Healthy volunteers
|
Dose oral
Oral dose
Oral dose
|
|
Experimental: Cohort 5
Healthy volunteers
|
Dose oral
Oral dose
Oral dose
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Prazo: 26 days
|
26 days
|
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Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Prazo: 26 days
|
26 days
|
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Incidence and severity of adverse events
Prazo: 26 days
|
26 days
|
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Changes from baseline in the QTcF interval
Prazo: 19 days
|
19 days
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
Prazo: 1 day
|
1 day
|
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PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
Prazo: 3 days
|
3 days
|
|
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
Prazo: 1 day
|
1 day
|
|
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
Prazo: 3 days
|
3 days
|
|
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
Prazo: 1 day
|
1 day
|
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PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
Prazo: 3 days
|
3 days
|
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PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
Prazo: 1 day
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1 day
|
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PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
Prazo: 3 days
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3 days
|
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PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
Prazo: 1 day
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1 day
|
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PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
Prazo: 3 days
|
3 days
|
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PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
Prazo: 1 day
|
1 day
|
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PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
Prazo: 3 days
|
3 days
|
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PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
Prazo: 1 day
|
1 day
|
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PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
Prazo: 3 days
|
3 days
|
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PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
Prazo: 1 day
|
1 day
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PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
Prazo: 3 days
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3 days
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PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
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PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
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PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
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PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
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1 day
|
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PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
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PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
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PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 1 day
|
1 day
|
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PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 5 days
|
5 days
|
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PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
|
6 days
|
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PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
Prazo: 6 days
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6 days
|
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PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
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19 days
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PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
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19 days
|
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PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
Prazo: 19 days
|
19 days
|
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Urine concentrations of ACHN-789 after single dose administration
Prazo: 1 day
|
1 day
|
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Urine concentrations of ACHN-383 after single-dose administration
Prazo: 3 days
|
3 days
|
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Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Prazo: 1 day
|
1 day
|
|
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
Prazo: 5 days
|
5 days
|
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Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
Prazo: 19 days
|
19 days
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Daniel J Cloutier, PharmD, Achaogen, Inc.
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)
17 de maio de 2017
Conclusão Primária (Real)
15 de outubro de 2017
Conclusão do estudo (Real)
15 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
15 de maio de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de maio de 2017
Primeira postagem (Real)
23 de maio de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de dezembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- ACHN-172-001
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 .
Ensaios clínicos em Placebo
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