NCT01105780

JNJ-41443532 Sex, Race, and Age Pharmacokinetic (PK) Study

Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-41443532 in Healthy Male and Female Caucasian and Male Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability 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 JNJ-41443532 in healthy male and female Caucasian and male Japanese 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, parallel group, single dose study in male and female Caucasian and male Japanese participants. The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) study in healthy male and female caucasian and male Japanese participants. For each participant, the study will consist of a screening examination (within 28 days of first dose on Day 1), a single period of open label treatment (all people involved know the identity of the intervention) upon entry in the study and discharge on Day 3), and a final, follow-up examination between 7-10 days after discharge from the study. Safety assessments include monitoring of adverse events, and evaluation of lab results, cardiac parameters, vital signs, and physical exams. Participants receive study medication (JNJ-41443532 or placebo) by mouth on Day 1 after an overnight fast of at least 10 hours; planned dose is 250 mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo
DRUG	JNJ-41443532	250mg tablet once daily for 1 day

Timeline

• Start date: 2010-05-01
• Completion: 2010-08-01
• First posted: 2010-04-16
• Last updated: 2014-04-08

Locations

1 site across 1 country: United States