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A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

12 de outubro de 2018 atualizado por: Janssen Research & Development, LLC

A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

40

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

      • Fukuoka, Japão, 812-0025
        • Souseikai Hakata Clinic
      • London, Reino Unido, NW10 7EW
        • Hammersmith Medicines Research Ltd

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

20 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
  • Body mass index (weight kg/m^2) between 18 and 27 kilogram per square meter (kg/m^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
  • Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
  • Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
  • Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
  • Clinically significant abnormal physical exam at Screening or Day -1
  • Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
  • Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1.
JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
Experimental: Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
Experimental: Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 2.5 mg/kg IV infusion on Day 1.
Experimental: Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 IV infusion (Dose to be determined).
Experimental: Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 IV infusion (Dose to be determined).
Experimental: Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Prazo: Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to Day 113
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Prazo: Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to Day 113

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Cmax is the maximum observed plasma concentration.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Total Systemic Clearance (CL) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Half-life is the time measured for the plasma concentration of drug to decrease by one half.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
CL/F is defined as total systemic clearance over bioavailability after SC administration.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
(Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375
Prazo: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
F is defined as absolute bioavailability after SC administration of JNJ-64179375.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Immunogenicity of JNJ-64179375
Prazo: Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.
Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
Prazo: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time (TT).
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
Prazo: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in prothrombin time (PT).
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
Prazo: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in activated partial thromboplastin time (aPTT).
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
Prazo: Predose, Day 1, 2, 4, and 14 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in Ecarin Clotting time (ECT).
Predose, Day 1, 2, 4, and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
Prazo: Predose, Days 1 and 14 post-dose
Platelet function will be assessed by measuring platelet activation and aggregation in response to thrombin and other agonists and with the platelet function analyzer (PFA)100.
Predose, Days 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
Prazo: Predose, Day 1 and 14 post-dose
The TGA is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual.
Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
Prazo: Predose, Day 1 and 14 post-dose
The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.
Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
Prazo: Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in international normalized ratio (INR).
Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
Prazo: Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose

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 (Real)

27 de junho de 2017

Conclusão Primária (Real)

25 de junho de 2018

Conclusão do estudo (Real)

25 de junho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

10 de março de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de março de 2017

Primeira postagem (Real)

15 de março de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de outubro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de outubro de 2018

Última verificação

1 de outubro de 2018

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CR108306
  • 2016-004785-25 (Número EudraCT)
  • 64179375EDI1002 (Outro identificador: Janssen Research & Development, LLC)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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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