- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01159821
A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
7 de abril de 2014 atualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label Study to Assess the Effect of CYP2D6 Inhibitor Paroxetine on the Single-Dose Pharmacokinetics of JNJ-31001074 in Healthy Subjects
The purpose of this study is to determine the concentration of 31001074 in blood samples from healthy volunteers who have been administered 31001074 and paroxetine.
Visão geral do estudo
Descrição detalhada
This is an open-label (both volunteer and study physician will know the identity of study treatment) pharmacokinetic study to determine the effects, if any that multiple 20-mg doses of paroxetine have on the concentration of a single dose of study drug (referred to as 31001074) in the bloodstream after paroxetine and 31001074 are administered orally (by mouth) to healthy adult volunteers.
Paroxetine is an approved drug used to treat patients with psychiatric disorders and 31001074 is a drug that is currently under development for potential uses in the treatment of patients with nervous system disorders.
Approximately 14 healthy volunteers will participate in the study for approximately 45 days (includes a screening period of up to 29 days to determine eligibility and a 16 day treatment period).
Volunteers will be required to stay overnight at the study center during the 16-day treatment period.
During the 16-day treatment period, volunteers will receive 2 doses of 31001074 and 12 doses of paroxetine.
At Screening, a blood sample will be collected from all volunteers for pharmacogenomic analysis (ie, genetic testing) to identify volunteers genetically-determined to have high activity of an enzyme (CYP2D6) that is involved in the processing of 31001074 by the body.
Additional blood samples will be obtained from volunteers at protocol-specified time points during the study to determine the concentration of 31001074 and paroxetine in plasma (the colorless portion of blood).
Safety will be evaluated during the study by monitoring adverse events (side effects) reported and findings from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed.
In addition, volunteers will be instructed to report the occurrence of adverse events that are considered by the study physician to be serious (as defined by the protocol) for up to 30 days after the administration of the last dose of study drug.
A single dose of 31001074 will be administered on Day 1 and Day 13 (total 2 doses).
Paroxetine will be administered once daily from Days 4 through 15 (total 12 doses).
All doses, including 31001074 and paroxetine will be administered at the same time (approximately 8 am), except on Day 13, when paroxetine will be administered 30 minutes (approximately 7:30 am) before the administration of 31001074.
Tipo de estudo
Intervencional
Inscrição (Real)
14
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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Kansas
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Overland Park, Kansas, Estados Unidos
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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 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Have a body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Have a blood pressure after the healthy volunteer is supine [ie, lying down face up] for 5 minutes between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and at admission to the study center on Day -1
- If a woman, must be of nonchildbearing potential, i.e., postmenopausal (no spontaneous menses for at least 2 years) or surgically sterile
- Be a nonsmoker
Exclusion Criteria:
- Have a history of or a current medical illness that the investigator (study physician) considers to be clinically significant, a history of chronic uveitis (inflammation of the eye persisting for a long time) or any any intraocular surgery (except for cataract extraction, laser in situ keratomileusis [LASIK], or photorefractive keratectomy [PRK] procedures [ie, procedures used to reshape the cornea of the eye])
- Have clinically significant abnormal laboratory values, abnormal ECG, or a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
- If a woman, be pregnant, lactating or completed last term pregnancy within 6 months before admission to study center on Day -1
- Have known allergy to heparin (agent used to prevent clotting of the blood) or history of heparin induced thrombocytopenia (low blood platelet count as a result of the medication heparin)
- Have intermediate or low activity of CYP2D6 as determined by genetic testing
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
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 001
31001074/paroxetine 1 tablet of 31001074 will be administered on Day 1 and Day 13.
One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
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1 tablet of 31001074 will be administered on Day 1 and Day 13.
One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Pharmacokinetic parameters (area under the plasma concentration-time curve [AUC] and the maximum plasma concentration [Cmax]) of 31001074 with and without the coadministration of paroxetine
Prazo: 0 to 72 hours after study drug administration on Day 1 and Day 13
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0 to 72 hours after study drug administration on Day 1 and Day 13
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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The number and type of adverse events and serious adverse events reported
Prazo: From screening (up to 29 days before study drug administration) through 30 days after Day 16 (study completion) or at the time of early withdrawal from the study
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From screening (up to 29 days before study drug administration) through 30 days after Day 16 (study completion) or at the time of early withdrawal from the study
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Results from clinical laboratory tests performed
Prazo: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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Findings from electrocardiograms (ECGs) and vital signs measurements performed
Prazo: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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Findings from physical examinations performed
Prazo: During screening (15 to 29 days before study drug administration) and on Day 16 or at the time of early withdrawal from the study
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During screening (15 to 29 days before study drug administration) and on Day 16 or at the time of early withdrawal from the study
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Columbia Suicide Severity Rating Scale (C-SSRS) scores to assess severity and track suicidal events during treatment
Prazo: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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 agosto de 2010
Conclusão do estudo (Real)
1 de outubro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
8 de julho de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de julho de 2010
Primeira postagem (Estimativa)
9 de julho de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de abril de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de abril de 2014
Última verificação
1 de abril de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Drogas Psicotrópicas
- Inibidores de Captação de Serotonina
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Agentes de Serotonina
- Antidepressivos
- Inibidores da enzima citocromo P-450
- Agentes antidepressivos de segunda geração
- Inibidores do citocromo P-450 CYP2D6
- Paroxetina
Outros números de identificação do estudo
- CR017242
- 31001074ATT1014 (Outro identificador: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
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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