NCT00910923

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers

Single Ascending Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-38431055.

Detailed description

The study includes 2 Parts and will be conducted at a single center. Part 1 is a randomized (study drug assigned by chance), double-blind (neither the volunteer or investigator knows the name of the assigned study drug), placebo-controlled (placebo is a substance that looks the same as JNJ-38431055 but contains no JNJ-38431055), single ascending dose study. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 or three treatment periods. In Part 1, for each volunteer, the study will consist of a screening evaluation visit, 3 periods of double-blind treatment, and a final, follow-up examination. The total study duration for each volunteer will be approximately 9 weeks. Part 2 is a randomized, open-label, 2-period crossover study to evaluate the effect of administering JNJ-38431055 together with food on the pharmacokinetics of JNJ-38431055, as compared to administration in the fasting condition. In Part 2, study drug (JNJ-38431055 will be administered orally as single doses on Day 1 or two treatment periods. There will be at least 7 days between doses. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 of three treatment periods. In Part 2, study drug (JNJ-38431055) will be administered orally as single doses on Day 1 of two treatment periods.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	JNJ-38431055

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-06-01
• Last updated: 2009-10-06