A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 20 - 55 |
Updated: | 4/17/2018 |
Start Date: | October 12, 2016 |
End Date: | February 4, 2017 |
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
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.
(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.
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
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