A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants

Janssen Pharmaceutical K.K.24 enrolled

Overview

The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral administration.

This is a single center, double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), randomized (study medication assigned to participants by chance), single-ascending dose study. The study consists of a screening phase, an in-clinic treatment phase, and a follow-up phase. The study duration for each subject will be approximately 5 weeks from screening (Day -28 to Day -3), in-clinic period (Day -2 to Day 4) to follow up visit (Day 8). Participants will receive a single oral dose of JNJ-42847922 or placebo in 3 cohorts. Participants' safety will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

JNJ-42847922, 5 mgDRUG

Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 on Day 1, fasted condition.

JNJ-42847922, 20 mgDRUG

Participants will receive single oral dose of 20 mg of JNJ-42847922 on Day 1, fasted condition.

JNJ-42847922, 40 mgDRUG

Participants will receive single oral dose of 40 mg of JNJ-42847922 on Day 1, fasted condition.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be willing and able to adhere to the prohibitions and restrictions specified inprotocol, Prohibitions and Restrictions * A man who is sexually active with a woman of childbearing potential and has not had avasectomy must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception), and all men must also agree not to donate sperm during the study and for 3 months afterreceiving the last dose of study drug * Participant must have a body mass index (BMI) between 18.0 and 29.9 kilogram per square meter (kg/m\^2), and body weight not less than 50 kg * Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, Including: Synus rhythm; Heart rate between 45 and 99 beats per minute (bpm); QT corrected according to Fridericia's formula (QTcF) interval less than or equal to (\<=)450 milliseconds (ms); QRS interval of \<=120 ms; PR interval \<=220 ms; Morphology consistent with healthy cardiac conduction and function * Nonsmoker (not smoked for 3 months prior to screening) Exclusion Criteria: * Participant has a history of or current clinically significant medical illness including (but notlimited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulationdisorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities,significant pulmonary disease, including bronchospastic respiratory disease, diabetesmellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease,infection, or any other illness that the investigator considers should exclude the participant orthat could interfere with the interpretation of the study results * Participant has a clinically significant abnormal value for hematology, coagulation,biochemistry, or urinalysis at screening as deemed appropriate by the investigator * Participant has a clinically significant abnormal physical examination, neurologic examination,or vital signs as deemed appropriate by the investigator * Use of any prescription or nonprescription medication (including vitamins and herbalsupplements), except for acetaminophen within 14 days before study drug administration onDay 1 * Participant has known allergies, hypersensitivity, or intolerance to JNJ-42847922 or its excipients

Locations (1)

Unnamed facility

Osaka, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: up to Day 8

Number of Participants With Serious Adverse Events (SAEs)

Time frame: up to Day 8

Secondary Outcomes

Maximum Plasma Concentration (Cmax)

Cmax is the maximum observed plasma concentration.

Time frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4

Time to Reach the Maximum Observed Plasma Concentration (Tmax)

Tmax is the time to reach the maximum observed plasma concentration.

Time to Last Time of the Last Measurable (nonbelow quantification limit [nonBQL]) Plasma Concentration (Tlast)

Tlast is the time to last time of the last measurable (nonbelow quantification limit \[nonBQL\]) plasma concentration.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.