Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
13 de novembro de 2015 atualizado por: Bristol-Myers Squibb
Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
Visão geral do estudo
Descrição detalhada
Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study
Tipo de estudo
Intervencional
Inscrição (Real)
58
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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Florida
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Orlando, Florida, Estados Unidos, 32809
- Orlando Clinical Research Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- DaVita Clinical Research
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Meet renal function criteria in one of four categories
Exclusion Criteria:
- Unstable or uncontrolled medical conditions
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: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group A (Normal renal function): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
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Outros nomes:
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Experimental: Group B (End Stage Renal Disease): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
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Outros nomes:
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Experimental: Group C (Moderate renal impairment): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
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Outros nomes:
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Experimental: Group D (Severe renal impairment): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant.
The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment.
Mild participants were counted as per their original allocation.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Maximum Observed Plasma Concentration (Cmax) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Unbound Maximum Observed Plasma Concentrations of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Tmax was defined as the time required to reach maximum observed plasma concentration.
Tmax was directly determined from the raw plasma concentration-time data.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Plasma Half-life (T-half) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Apparent Total Body Clearance (CLT/F) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Unbound Apparent Clearance (CLU/F) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Percent Urinary Recovery (%UR) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods.
The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Renal Clearance (CLR) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Apparent Volume of Distribution (Vd/F) of Daclatasvir
Prazo: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.
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Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died
Prazo: First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs
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Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.
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First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs
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Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events
Prazo: Baseline up to Day 5 post dose
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Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.
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Baseline up to Day 5 post dose
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Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events
Prazo: Baseline up to Day 5 post dose
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The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.
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Baseline up to Day 5 post dose
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Number of Participants With Out-of-range Vital Signs Reported as Adverse Events
Prazo: Baseline up to Day 5 post dose
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The total number of participants with abnormal range vital signs which were considered as adverse events was determined.
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Baseline up to Day 5 post dose
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Colaboradores e Investigadores
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Patrocinador
Publicações e links úteis
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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
1 de setembro de 2012
Conclusão Primária (Real)
1 de junho de 2013
Conclusão do estudo (Real)
1 de junho de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
10 de abril de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de abril de 2013
Primeira postagem (Estimativa)
12 de abril de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de novembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de novembro de 2015
Última verificação
1 de novembro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AI444-063
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 .