- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02160756
Bioavailability Study of 3 Tablet Formulations vs. Capsule Formulation of JNJ-56021927 in Fasting Healthy Male Participants
19 de outubro de 2016 atualizado por: Aragon Pharmaceuticals, Inc.
A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Relative Bioavailability of 3 Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 Under Fasted Conditions in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a drug enters and leaves the blood and tissues over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-56021927, when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule formulation (reference) in healthy male participants under fasted conditions at a single dose of 240 milligram (mg).
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, 4-treatment, parallel design (a medical research study comparing the response in two or more groups of participants receiving different interventions) study of a single dose of 240 mg JNJ-56021927.
The duration of study will be approximately of 78 days per participant.
The study consists of 3 parts: Screening phase (that is, 21 days before study commences on Day 1); Open-label Treatment phase (consists of 4 parallel single-dose treatments); and End-of-Study (completion of the Hour 1344 PK sampling on Day 57, or upon early withdrawal).
All the eligible participants will be randomly assigned to 1 of the 4 possible treatments: Treatment A (240 mg dose as softgel capsule); Treatment B (240 mg dose as Tablet Formulation 1); Treatment C (240 mg dose as Tablet Formulation 2); or Treatment D (240 mg dose as Tablet Formulation 3).
Participants will fast overnight from food and fluids (excluding non-carbonated water) for at least 10 hours before study drug administration on Day 1. Blood samples will be collected pre-dose and over 1,344 hours (Day 57) after dosing for the determination of JNJ-56021927 concentration and its active metabolite.
Relative bioavailability of 3 tablet formulations as compared to the softgel capsule formulation of JNJ-56021927 will be evaluated primarily.
Participants' safety will be monitored throughout the study.
Tipo de estudo
Intervencional
Inscrição (Real)
75
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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Arizona
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Tempe, Arizona, 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
Macho
Descrição
Inclusion Criteria:
- Must agree to use an adequate contraception method as deemed appropriate by the investigator, always use a condom during sexual intercourse, and to not donate sperm during the study and for 3 months after receiving the study drug
- Body mass index between 18 and 30 kilogram (kg) per square meter, and body weight not less than 50 kg
- Blood pressure (supine for 5 minutes) between 90 and 140 millimeter of mercury (mm Hg) systolic, and no higher than 90 mm Hg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including pulse rate between 45 and 99 beats per minute (bpm), QT corrected Fridericia (QTcF) interval less than or equal to 450 milliseconds (msec), QRS interval of less than 120 msec, PR interval less than 220 msec, morphology consistent with healthy cardiac conduction and function
- Nonsmoker within the previous 2 months
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection
- Known hypersensitivity to Vitamin E
- History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
- Known allergy to the study drug or any of the excipients of the formulation
- Unable to swallow solid, oral dosage forms whole with the aid of water
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Treatment A
Single oral dose of JNJ-56021927 240 milligram (mg) softgel capsule on Day 1.
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Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.
Outros nomes:
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Experimental: Treatment B
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
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Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
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Experimental: Treatment C
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
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Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
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Experimental: Treatment D
Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
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Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
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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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Maximum Plasma Concentration (Cmax)
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The Cmax is the maximum observed plasma concentration.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Time to Reach Maximum Concentration (Tmax)
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The Tmax is time to reach the maximum observed plasma concentration.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time 72 Hours (AUC [0-72])
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72 hours post-administration of drug on Day 1
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time 72 Hours (AUC [0-72]) will be evaluated.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72 hours post-administration of drug on Day 1
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time 168 Hours (AUC [0-168])
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168 hours post-administration of drug on Day 1
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time 168 Hours (AUC [0-168]) will be evaluated.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168 hours post-administration of drug on Day 1
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Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-last]) will be evaluated.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)]
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and Clast/lambda(z), wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Extrapolated Area Under the Curve (AUC Percent [%] Extrap)
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The AUC%extrap is the percentage of AUC [0-infinity] obtained by forward extrapolation.
It is calculated as (AUC [0-infinity] minus AUC [0-last])*100/ AUC [0-infinity], where AUC [0-infinity] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Elimination Half-Life (t1/2)
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.
Elimination half-life associated with the terminal slope of the semi-logarithmic drug concentration-time curve, calculated as 0.693/elimination rate constant (lambda[z]).
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Elimination Rate Constant (lambda[z])
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Elimination rate constant is the fraction of a drug that is removed from the body per unit time.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Time to Last Quantifiable Plasma Concentration (Tlast)
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The Tlast is time to reach the last quantifiable plasma concentration.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Relative Bioavailability
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action.
Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])
Prazo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).
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Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 , 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1176, 1344 hours post-administration of drug on Day 1
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Prazo: Screening up to Day 57 or early withdrawal
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to day 57, that are absent before treatment or that worsened relative to pretreatment state.
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Screening up to Day 57 or early withdrawal
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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 novembro de 2014
Conclusão do estudo (Real)
1 de novembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2014
Primeira postagem (Estimativa)
11 de junho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
20 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de outubro de 2016
Última verificação
1 de outubro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CR104824
- 56021927PCR1011 (Outro identificador: Janssen Research & Development, LLC)
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 JNJ-56021927 Softgel Capsule
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Janssen Pharmaceutical K.K.Concluído
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Aragon Pharmaceuticals, Inc.Concluído
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Janssen Research & Development, LLCRecrutamentoInsuficiência HepáticaEstados Unidos
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Ativo, não recrutandoAdenocarcinoma de próstata | Câncer de Próstata Estágio IIB AJCC v8Estados Unidos
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Aragon Pharmaceuticals, Inc.Não está mais disponívelNeoplasias prostáticasColômbia, Brasil, México
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University of WashingtonNational Cancer Institute (NCI); Janssen Scientific Affairs, LLCRescindidoAdenocarcinoma de próstataEstados Unidos
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National Cancer Institute (NCI)RecrutamentoAdenocarcinoma de próstata | Carcinoma de Próstata Localizado | Câncer de Próstata Estágio I AJCC v8 | Câncer de Próstata Estágio II AJCC v8Estados Unidos
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Janssen Pharmaceutical K.K.ConcluídoNeoplasias Prostáticas Resistentes à CastraçãoJapão
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Janssen Research & Development, LLCAtivo, não recrutando
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National Cancer Institute (NCI)Ainda não está recrutandoCarcinoma Urotelial de Bexiga Não Músculo Invasivo | Carcinoma Urotelial de Bexiga Não Músculo Invasivo RecorrenteEstados Unidos