A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335 will also be evaluated during the study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study

• Agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

• Have a body mass index (weight [kg]/height2 [m]2) (BMI) between 18 and 30 kg/m2 (inclusive), body weight not less than 50 kg, blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg, systolic, inclusive, and no higher than 90 mmHg diastolic, and an electrocardiogram with results consistent with normal cardiac conduction and function

• Non-smoker for at least 3 months

Exclusion Criteria:

• History of or current medical illness, laboratory values, vital signs, physical examination findings, or electrocardiogram findings deemed clinically significant by the Investigator