A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
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.
Drug: JNJ-31001074; ketoconazole
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of JNJ-31001074 in Healthy Subjects|
- 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 [ Time Frame: Multiple blood samples will be obtained over the 11 day open-label treatment phase ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole [ Time Frame: up to 32 days (including a 21 day screening phase) ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||December 2009|
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), sequential design (one after the other) 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. During the screening phase, healthy volunteers will be evaluated to see if they meet selection criteria as specified in the protocol. Healthy volunteers who meet these criteria will report to the study center on Day -1. Volunteers will be admitted to the study center and will fast (no food or beverages) overnight for at least 10 hours. Volunteers will remain at the study center for 11 days. The open-label treatment phase consists of three periods. In Period 1, a single-dose of JNJ-31001074 10 mg will be administered on Day 1, followed by three days of multiple blood sampling (Days 1-3). In Period 2 (Days 4-6), 400 mg ketoconazole will be administered on each day just prior to which predose blood samples are taken. In Period 3 (Days 7-11), JNJ-31001074 10 mg and ketoconazole 400 mg will be administered together on Day 7, followed by four days of multiple blood sampling. Ketoconazole will also be administered on Day 8 and Day 9 of Period 3. No study drug will be administered on Days 2 and 3 of Period 1, and Days 10 and 11 of Period 3. The end-of-study phase assessments will be performed after the completion of the four day blood sampling on Day 11. Safety and tolerability will be assessed throughout the volunteer's participation. Volunteers will be instructed to report any adverse events that occur up to 30 days after their last dose of study drug. The maximum study duration for each volunteer is expected to be 32 days. JNJ-31001074 10 mg will be administered orally on Days 1 and 7; ketoconazole 400 mg will be administered orally on Days 4, 5, 6, 7, 8, and 9.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|