A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Cilag N.V./S.A.

Criteria

Inclusion Criteria:

• Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1

• Must have good exercise tolerance

• Agrees to protocol-defined use of effective contraception

• Body Mass Index between 20 and 30 kg/m2 and body weight not less than 65 kg

• Non-nicotine user for 6 months prior to screening

Exclusion Criteria:

• Current history of clinically significant medical illness

• History of drug or alcohol abuse within 5 years

• Routine consumption of >450 mg of caffeine per day

• Recent vaccination or acute illness

• Blood donation or major blood loss within 3 months prior to study drug administration

• Use of any prescription or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of dosing of the study drug or a proton pump inhibitor within 6 weeks prior to dosing of study drug

• Currently enrolled in an investigational study, or received an investigational drug or vaccine, or used an invasive investigational medical device within 3 months before the planned first dose of study drug

• Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug

• Major surgery within 3 months before or after study participation or minor surgery within 6 weeks before screening, or 30 days after the last study drug administration

• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments