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- Ensaio Clínico NCT02156492
A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants
18 de fevereiro de 2018 atualizado por: Eli Lilly and Company
A Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Study of Evacetrapib With Selected Statins in Healthy Chinese Subjects
The main purpose of this study is to investigate how the body responds to evacetrapib and to evaluate the safety and the effect of evacetrapib, alone and in combination with selected statins, in healthy Chinese participants.
The study has 2 parts.
Part one will last up to 4 weeks and part two will last up to 5 weeks, not including screening.
Participants may only enroll in one part.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
62
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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Beijing, China, 100034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Are native Chinese and living in China.
- Are overtly healthy males or females as determined by medical history and physical examination.
Female participants:
- Women not of child-bearing potential
- Women of child-bearing potential must correctly use 2 forms of reliable contraception to avoid getting pregnant during the study and for 3 months after the study is completed.
- Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)
- BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg
- Participants with untreated hypercholesterolemia may be included if not on an herbal or other traditional Chinese medicines (TCM)
- Have no known liver disease
- Have given written informed consent
Exclusion Criteria:
- Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have known allergies to evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation
- Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.
- Have a history within the last year or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
- Show evidence of significant active neuropsychiatric disease.
- Regularly use known drugs of abuse
- Are women with a positive pregnancy test or women who are lactating.
Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the study.
- Hormonal contraceptives are permitted.
- Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other transporters involved in simvastatin or atorvastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of cytochrome P450 3A (CYP3A) within 30 days prior to the first dose and throughout the study.
- Donated blood of >400 mL within the last month.
- Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing until discharge from the clinical research unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
- Are unwilling to comply with the dietary requirements/restrictions during the study
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Evacetrapib Single
Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.
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Administered orally.
Outros nomes:
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Experimental: Evacetrapib Multiple
Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days.
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Administered orally.
Outros nomes:
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Comparador Ativo: Simvastatin
Part 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4.
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Administrado por via oral.
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Experimental: Evacetrapib and Simvastatin
Part 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22.
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Administrado por via oral.
Administered orally.
Outros nomes:
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Comparador Ativo: Atorvastatin
Part 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4.
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Administrado por via oral.
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Experimental: Evacetrapib and Atorvastatin
Part 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22.
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Administrado por via oral.
Administered orally.
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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Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib
Prazo: Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose
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Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.
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Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose
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PK: Maximum Concentration (Cmax) of Evacetrapib
Prazo: Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose
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Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.
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Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose
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PK: Time to Maximum Concentration (Tmax) of Evacetrapib
Prazo: Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.
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Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.
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Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.
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PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin
Prazo: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose
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Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).
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Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose
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PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
Prazo: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.
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Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.
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Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.
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PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
Prazo: Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.
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Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin.
Tmax of simvastatin and atorvastatin.
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Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
Prazo: Single Dose Day 2 and Multiple Dose Day 22
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Single Dose Day 2 and Multiple Dose Day 22
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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 junho de 2014
Conclusão Primária (Real)
1 de dezembro de 2014
Conclusão do estudo (Real)
1 de dezembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
28 de maio de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de junho de 2014
Primeira postagem (Estimativa)
5 de junho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de outubro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de fevereiro de 2018
Última verificação
1 de fevereiro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14467
- I1V-MC-EIAM (Outro identificador: Eli Lilly and Company)
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 .
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