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

NCT ID: NCT02555124

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-12
• Study Completion Date: 2015-10-31

Brief Summary

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

Detailed Description

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.

Conditions

Healthy

Study Design

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

Study Groups

Cohort A

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

Group Type: EXPERIMENTAL

JNJ-42847922, 5 mg

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.

Cohort B

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

Group Type: EXPERIMENTAL

JNJ-42847922, 20 mg

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.

Cohort C

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

Group Type: EXPERIMENTAL

JNJ-42847922, 40 mg

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.

Interventions

JNJ-42847922, 5 mg

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

Intervention Type: DRUG

JNJ-42847922, 20 mg

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

Intervention Type: DRUG

JNJ-42847922, 40 mg

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

Intervention Type: DRUG

Placebo

Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Osaka, , Japan

Countries

Japan

Other Identifiers

42847922ISM1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR107878

Identifier Type: -

Identifier Source: org_study_id