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An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of JNJ-31001074 in Healthy Subjects
This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of study/early withdrawal assessment phase.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 14 |
| Start date | 2009-11 |
| Completion | 2009-12 |
Conditions
- Healthy
- Pharmacokinetics
- Drug Interactions
Interventions
- JNJ-31001074; ketoconazole
Primary outcomes
- The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers — Multiple blood samples will be obtained over the 11 day open-label treatment phase