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A Double-Blind, Randomized, Single- and Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Healthy Adult Male Subjects and an Open-Label Drug-Drug Interaction Study to Evaluate the Effect of JNJ-38518168 on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate
The purpose of Part 1 of this study is to evaluate the safety, tolerability, and pharmacokinetics ("PK", how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the pharmacokinetics of midazolam in healthy participants.
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 94 |
| Start date | 2011-09 |
| Completion | 2012-07 |
Conditions
- Healthy Male Volunteer
Interventions
- JNJ-38518168 (30 mg)
- JNJ-38518168 (10 mg)
- JNJ-38518168 (3 mg)
- Placebo
- Midazolam and JNJ-38518168
Primary outcomes
- The number of Japanese participants with adverse events — Up to 10 weeks
- Blood tests in Japanese participants — Up to 10 weeks
- Clinical laboratory tests in Japanese participants — Up to 10 weeks
- Electrocardiograms in Japanese participants — Up to 10 weeks
- Blood levels of JNJ-38518168 in all participants — Up to 10 weeks
Countries
United States