Status:
COMPLETED
A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 fo...
Detailed Description
This is an open-label (the name of the study drug will be known to the healthy volunteers participating in this study as well as to all study staff), randomized (volunteers will be assigned by chance ...
Eligibility Criteria
Inclusion
- 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
- History of or current medical illness, laboratory values, vital signs, physical examination findings, or electrocardiogram findings deemed clinically significant by the Investigator
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01454245
Start Date
July 1 2011
End Date
April 1 2012
Last Update
January 31 2013
Active Locations (1)
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1
Overland Park, Kansas, United States