NCT01964872

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

A Double Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Janssen Cilag N.V./S.A. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 contains up to 3 subparts: Part 1a is a double-blind, placebo-controlled, single ascending dose design (SAD) with a liquid formulation (Formulation A); Part 1b is an open-label (identity of assigned study drug will be known), single dose evaluation of a capsule formulation (Formulation B); and Part 1c is an optional open-label, single dose evaluation of a capsule formulation (Formulation C). Part 2 is the completion of the double-blind, placebo-controlled SAD after a formulation has been selected based on Parts 1a, 1b, and 1c (if applicable). Part 3 is a double-blind, placebo-controlled, multiple ascending dose design (MAD). Doses for Part 3 will be determined based on the safety, tolerability, and pharmacokinetics (study of what the body does to a drug) in Parts 1 and 2. Part 4 is an optional double-blind, placebo-controlled, single dose evaluation in older healthy male participants. Serial pharmacokinetic and pharmacodynamics (study of what a drug does to the body) samples will be collected and safety will be monitored throughout the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	JNJ-38877618: Part 1a	Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
DRUG	JNJ-38877618: Part 1b	Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
DRUG	JNJ-38877618: Part 1c (optional)	Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
DRUG	JNJ-38877618: Part 2	Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
DRUG	JNJ-38877618: Part 3	Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.
DRUG	JNJ-38877618: Part 4 (optional)	Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.
DRUG	Placebo: Parts 1a, 2, 3, and 4 (optional)	Administered orally matched to study drug

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-10-17
• Last updated: 2014-09-12

Locations

1 site across 1 country: United Kingdom