A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants

NCT ID: NCT02933580

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-12
• Study Completion Date: 2017-02-04

Brief Summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A: JNJ-56136379 (25 mg) or Placebo

Participants will receive a single oral dose of 25 milligram (mg) of JNJ-56136379 (1\*25-mg tablet) or placebo on Day 1, fasted conditions.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.

Placebo

Intervention Type: OTHER

Participants will receive matching placebo tablets on Day 1.

Cohort B: JNJ-56136379 (150 mg) or Placebo

Participants will receive a single oral dose of 150 mg of JNJ-56136379 (2\* 25-mg tablet and 1\*100-mg tablet) or placebo on Day 1, fasted conditions.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.

Placebo

Intervention Type: OTHER

Participants will receive matching placebo tablets on Day 1.

Cohort C: JNJ-56136379 (300 mg) or Placebo

Participants will receive a single oral dose of 300 mg of JNJ-56136379 (3\*100-mg tablet) or placebo on Day 1, fasted conditions.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.

Placebo

Intervention Type: OTHER

Participants will receive matching placebo tablets on Day 1.

Cohort D: JNJ-56136379 (600 mg) or Placebo

Participants will receive a single oral dose of 600 mg of JNJ-56136379 (6\*100-mg tablet) or placebo on Day 1, fasted conditions.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.

Placebo

Intervention Type: OTHER

Participants will receive matching placebo tablets on Day 1.

Interventions

JNJ-56136379

Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo tablets on Day 1.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese as determined by participant's verbal report
• Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical and surgical history, vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed/signed by the investigator
• Participant must have a body mass index (BMI; weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square [kg/m^2], extremes inclusive, and body weight not less than 45.0 kg
• Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of the triplicate parameters) at screening including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (<=)450 millisecond (ms); QRS interval less than (<)120 ms; PR interval <=220 ms
• A female participant (except if permanently sterile), should have a negative serum pregnancy test at screening and all female participants should have a negative urine pregnancy test on Day -1

Exclusion Criteria

• Participant with a past history of cardiac arrhythmias (example [eg], extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
• Female participant who is breastfeeding at screening or pregnant at screening or predose
• Male participant planning to father a child while enrolled in this study or within 90 days after study drug administration
• Participant with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at Screening
• Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at Screening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Glendale, California, United States

Countries

United States

Other Identifiers

56136379HPB1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108247

Identifier Type: -

Identifier Source: org_study_id