A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01454245
- Run by
- Janssen Research & Development, LLC
- People needed
- 43
- Starts
- 2011-07-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2013-01-31
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- History of or current medical illness, laboratory values, vital signs, physical examination findings, or electrocardiogram findings deemed clinically significant by the Investigator
Where it is running
- Study site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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