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
Condition: Healthy Male Volunteer
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Participants will be assigned to either Part 1 or Part 2 of this study. Part 1 will be a
      single-center, double-blind (participants and study personnel will not know the identity of
      the treatments), randomized (treatment will be assigned by chance), single- and multiple-dose
      study. There will be 3 groups in Part 1, and the dosing will be as follows: Group A will
      receive a single oral dose of 30 mg JNJ-38518168 (given as three 10-mg tablets of
      JNJ-38518168) or placebo (a treatment identical in appearance to JNJ-38518168 but not
      containing active drug) (Period 1), and multiple oral doses of 30 mg JNJ 38518168 (given as
      three 10-mg tablets of JNJ-38518168) or matching placebo once daily for 14 consecutive days
      (Period 2); Group B will receive a single oral dose of 10 mg JNJ-38518168 or placebo (Period
      1), and multiple oral doses of 10 mg JNJ-38518168 or placebo once daily for 14 consecutive
      days (Period 2); and Group C will receive a single oral dose of 3 mg JNJ-38518168 or placebo
      (Period 1), and multiple oral doses of 3 mg JNJ-38518168 or placebo once daily for 14
      consecutive days (Period 2). At least a 20-day washout period will separate the dose
      administration in Period 1 and the first dose administration of Period 2. The duration of
      Part 1 will be approximately 78 days. Part 2 of this study will be a single-center,
      open-label (participants and study personnel will know the identity of the treatments),
      non-randomized, multiple dose, drug-drug interaction study. Eligible participants will
      receive a single oral dose of 2.5 mg of midazolam as oral solution on Day 1, three 10-mg
      tablets of JNJ-38518168 (30 mg) once daily for 14 consecutive days (Day 2 through Day 15);
      and another single oral dose of 2.5 mg midazolam on Day 15. The duration of Part 2 of the
      study will be approximately 42 days. Following an interim safety and PK data analysis, one
      additional treatment group may be studied to evaluate the effect of JNJ-38518168 at a dose
      lower than 30 mg once daily on the PK of midazolam. During Parts 1 or 2, participants may be
      admitted to the clinical unit for periods of up to 7 and 18 days, and follow-up return visits
      to the clinic will also be required.
    

Intervention name(s): JNJ-38518168 (30 mg); JNJ-38518168 (10 mg); JNJ-38518168 (3 mg); Placebo; Midazolam and JNJ-38518168
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days; Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days; Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days; Form=tablet, route=oral use, for 14 days; Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy male volunteer; JNJ-38518168; Midazolam