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

Launched by JANSSEN CILAG N.V./S.A. · Oct 15, 2013

Keywords

ClinConnect Summary

This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in healthy adult male participants aged 18 to 45 years (a single optional cohort in older healthy male participants aged 50 to 65 years may be included). If all optional cohorts are included, up to 144 participants may be enrolled. This study will consist of up to four parts. Part 1 con...

Gender

MALE

Eligibility 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

Trial Officials