NCT01106469

Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of Single and Multiple Ascending Doses of JNJ-41443532 in Healthy Male Participants

Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of JNJ-41443532 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability, food effect as well as the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and how it is removed from the body over time) and pharmacodynamics (the effects of the drug) of single and multiple ascending doses of JNJ-41443532 in healthy male participants.

Detailed description

This is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled, single and multiple ascending dose study conducted at a single study center. The study has 4 parts. Part 1 is a randomized, double-blind, alternating panel, single ascending oral dose study. Two alternating treatment panels (A and B) each with nine healthy male participants will be studied with successively increasing dose levels. Part 2 is a randomized, open-label (all people involved know the identity of the intervention), 2-period crossover study to evaluate what the effect of administering JNJ- 41443532 with food (i.e. standard high fat breakfast meal) relative to administration in the fasted state will have on pharmacokinetics/blood levels of JNJ-41443532. Part 3 is a randomized, double-blind, single oral dose study in obese, otherwise healthy male participants. Part 4 is a double-blind, randomized, placebo-controlled multiple ascending dose study in up to 5 sequential treatment groups of healthy male participants. Safety assessments include monitoring of adverse events, and evaluation of lab results, cardiac parameters, vital signs, and physical exams. In Parts 1, 2, and 3 participants receive study medication (JNJ-41443532 or placebo) orally on Day 1 after an overnight fast of at least 10 hours; planned doses are 25 to 1500 mg. In Part 4, participants receive study medication (JNJ-41443532 or placebo) orally each day for 10 consecutive days after an overnight fast of at least 10 hours; planned doses are 100 to 1000 mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-41443532	25mg tablet once daily
DRUG	JNJ-41443532	250mg tablet once daily
DRUG	JNJ-41443532	1500mg once daily (with 250mg tablets)
DRUG	JNJ-41443532	100mg tablet once daily
DRUG	JNJ-41443532	1000mg once daily (with 250mg tablets)
DRUG	Placebo	Matching placebo
DRUG	JNJ-41443532	500mg once daily (with 250mg tablets)

Timeline

• Start date: 2010-02-01
• Completion: 2010-07-01
• First posted: 2010-04-20
• Last updated: 2014-04-08

Locations

1 site across 1 country: Belgium