NCT01650597

A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants

A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses as well as repeated doses of JNJ-42165279 in healthy male participants.

Detailed description

This is a single-site, randomized (participants are assigned to treatment by chance), double-blind study (neither physician nor participant knows whether the participant is receiving active treatment or placebo). Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. This study consists of two parts (part 1, single dosing and part 2, multiple dosing). Part 1: An alternating panel design will be used, whereby the first panel of 9 participants will receive the first, third, and fifth administered doses, while the second panel of 9 participants will receive the second, fourth, and sixth administered doses.Up to 2 additional dosings (1 per panel) may be evaluated to further understand the study drug. For each dose administration, 6 participants will be assigned to active treatment and 3 to placebo. Each participant will receive JNJ-42165279 on 2 occasions and placebo once during the first 3 dosings. The planned doses of JNJ-42165279 range from 2.5 to 500 mg. The sponsor and investigator will review blinded data associated with each dose prior to administration of the next dose. Participants will check into the study center the morning prior to each dosing (Day -1) and will remain at the center until discharge 72 hours after dosing (Day 4). Participants will be dosed approximately every 4 weeks. Part 2: A separate cohort of 9 healthy male volunteers will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo (6 participants will receive JNJ-42165279 and 3 participants will receive placebo) for 6 consecutive days. Participants will check into the study center the morning prior to their first dosing (Day -1) and will remain at the center until discharge 72 hours after receiving their last dose on Day 6. Participants in Part 1 and 2 will return for a follow-up visit 7 to 14 days after their final discharge from the study center.

Conditions

• Healthy Volunteers
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	JNJ-42165279 2.5 - 500 mg oral	Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally.
DRUG	Placebo	Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.
DRUG	JNJ-42165279 100 mg oral	Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-07-26
• Last updated: 2017-07-06

Locations

1 site across 1 country: Belgium