A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
Condition: Healthy; Pharmacokinetics; Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): JNJ-31001074; ketoconazole
Intervention type(s): Drug
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Phase I; ketoconazole; CYP3A4 inhibitor; drug interaction; metabolism; Healthly Volunteer; JNJ-31001074