TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study
10 de outubro de 2012 atualizado por: Tibotec Pharmaceuticals, Ireland
A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations
The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules.
After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal.
This will be done in healthy volunteers.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers.
Crossover means that participants may receive different interventions sequentially during the trial.
Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin.
Open-label means that you and your physician will know what treatment you will receive.
The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase.
Total study duration for an individual participant will be up to 6 or 7 weeks.
Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase.
In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance.
Treatment A is a single dose of TMC345 as one formulation (1 capsule).
Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule).
Both treatments will be taken without food.
In between the 2 sessions, there will be at least 7 days.
In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance.
All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part.
In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast.
In between the sessions, there will be at least 7 days.
For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after.
The 3 following mornings, participants will come back to the study center.
Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase).
During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug).
In every treatment session, a single oral 150 mg TMC435 capsule will be given.
One formulation will be a gelatin capsule.
The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.
Tipo de estudo
Intervencional
Inscrição (Real)
48
Estágio
- Fase 1
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 55 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Non-smokers for at least 3 months prior to screening
- Have a body mass index of 18.0 to 30.0 kg per square meter
- Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening
Exclusion Criteria:
- Use of disallowed therapies, including over-the-counter products and dietary supplements
- Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
- Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
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 cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 001
TMC435 gelatin capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule without food
|
|
Experimental: 002
TMC435 HPMC capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule without food
|
|
Experimental: 003
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
|
Experimental: 004
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
|
Experimental: 005
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule
Prazo: Over 72 hours for every treatment session
|
Over 72 hours for every treatment session
|
|
Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state
Prazo: Over 72 hours for every treatment session
|
Over 72 hours for every treatment session
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Number of participants with adverse events and the severity of adverse events
Prazo: During maximum 7 weeks
|
During maximum 7 weeks
|
|
Percentage of abnormal values for laboratory parameters
Prazo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Observed values and changes from baseline of cardiovascular variables
Prazo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Prazo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Physical examination findings and changes from baseline.
Prazo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 março de 2011
Conclusão do estudo (Real)
1 de junho de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
3 de março de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de março de 2011
Primeira postagem (Estimativa)
4 de março de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de outubro de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de outubro de 2012
Última verificação
1 de outubro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças do Fígado
- Infecções por Flaviviridae
- Hepatite, Viral, Humana
- Hepatite
- Hepatite C
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Inibidores Enzimáticos
- Inibidores de Protease
- Simeprevir
Outros números de identificação do estudo
- CR015940
- TMC435-TiDP16-C116
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