Clinical trial NCT02933580: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants
Official title: A Double-blind, Placebo-controlled, Randomized, Phase 1, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 29 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 29 days
measure: Area Under the Concentration-Time Curve from time 0 to the Time of the Last Measurable non-Below Quantification Limit Concentration (AUC [0-last])
timeFrame: Up to 29 days
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: Up to 29 days
measure: Number of Participants With Adverse events as a Measure of Safety and Tolerability
timeFrame: 30-35 days after study drug intake (approximately 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: