A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics (what a medication does to the
      body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose
      oral administration of two solid oral formulations in Part 1; based on the profile in Part 1,
      one of the formulations assessed will be selected to investigate the pharmacokinetics in
      fasting condition in Part 2 and after repeated dosing in Part 3.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) and single center
      study that will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3
      phases including, the screening phase, treatment phase, and the follow-up phase. Part 1 is a
      four-way cross-over (method used to switch participants from one treatment arm to another in
      a clinical study) study to compare the pharmacokinetics, dose-proportionality, safety and
      tolerability of JNJ 39393406 following single dose oral administration of two solid oral
      formulations (X and Y). Approximately 12 participants will be enrolled in Part 1. Part 2 is
      two-way cross-over study in a separate group of participants to assess pharmacokinetics in
      fasting condition and the relative bioavailability (the extent to which a medication or other
      substance becomes available to the body) of the selected solid formulation from Part 1
      compared with a solution formulation. Approximately 8 participants will be enrolled in Part
      2. In Part 3, the single and repeated dose pharmacokinetics after administration of the
      selected formulation from Part 1 will be assessed for 7 consecutive days. The same
      participants will participate in Parts 2 and 3 of the study. Safety will be evaluated by the
      assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs,
      physical examination, and neurological examination. The duration of participation in the
      study for an individual participant will be approximately 8 weeks (including screening and
      follow up visit).
    

Intervention name(s): JNJ 39393406 30 mg solid X; JNJ 39393406 30 mg solid Y; JNJ 39393406 120 mg solid X; JNJ 39393406 120 mg solid Y; JNJ 39393406 30 mg solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).; Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).; Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).; Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).; Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-39393406; Relative Bioavailability; Solid Formulation