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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Placebo

Drug: JNJ-56136379

Study type

Interventional

Funder types

Industry

Identifiers

NCT02933580

CR108247

56136379HPB1003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: JNJ-56136379

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

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: JNJ-56136379

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

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: JNJ-56136379

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

Experimental group