drugset / Trial / NCT01442532
A Study of the Safety and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Male Participants and the Effect of JNJ-38518168 on the Blood Levels of Midazolam
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2011-09
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 2.5 mg | Oral |
| Subject | TOREFORANT | Small molecule | 3 mg | Oral |
| Subject | TOREFORANT | Small molecule | 10 mg | Oral |
| Subject | TOREFORANT | Small molecule | 30 mg | Oral |
Indications
No indication recorded.