A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers

Health Clinical Trial

Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-40346527 in Healthy Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.

Clinical Trial Description

JNJ-40346527 is an experimental drug that is being tested to see if it may be useful in treating of rheumatoid arthritis and other inflammatory diseases. This study will compare the effects (both good and bad) of JNJ-40346527 to those of placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study will be the first study in which JNJ-40346527 is given to humans. This study is being conducted in three parts. Parts 1 and 2 are randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) studies comparing the safety and tolerability of JNJ-40346527 to placebo in 96 healthy volunteers. Part 3 is an open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-40346527 in 8 healthy male volunteers. For Part 1, the participation period is a maximum of 64 days, including a screening visit, a 5-day in-clinic period and three follow-up visits. For Part 2, the participation period is a maximum of 83 days, including a screening visit, an 18-day in-clinic period and two follow-up visits. For Part 3, the participation period is a maximum of 59 days, including a screening visit, two 4-day in-clinic periods separated by a 7 day break, and a follow-up visit. For all three parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Volunteers will participate in 1 of 3 parts; Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-40346527 (10, 50, 150, 300, 600, or 1000mg) or placebo; Part 2: volunteers will receive oral doses of JNJ-40346527 (50, 150, 300, 500 or 750mg) or placebo once a day for 14 days; Part 3: volunteers will receive two oral doses of 150mg of JNJ-40346527 with and without food, with a 7-day break between doses. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health

• NCT number: NCT01054014
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Completion date: January 2011