A Study to Evaluate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of a single dose of
      two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part
      1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of
      absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to
      explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent
      of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).
    

Detailed description: 
      This is an open-label (both physician and participants know the identity of the intervention)
      and single centre study. This study will be conducted in 3 parts (Part 1, Part 2, and Part
      3). The study consists of 3 phases including, the screening phase (within 21 days prior to
      the start of study medication), treatment phase (Part 1: 20 days; Part 2: 12 days; Part 3: 16
      days), and the follow-up phase (Part 1 and Part 2: approximately 14 days after the last
      administration of study medication and Part 3: 14 days after the last administration of
      ketaconazole). Approximately 36 participants will be enrolled in the study (12 participants
      in each part). Part 1 is randomized (study medication is assigned by chance) and 3-way
      cross-over (method used to switch participants from one treatment arm to another in a
      clinical study) part of the study. Participants in Part 1 will be randomly assigned to 1 of 3
      treatment sequences (Period 1, Period 2, and Period 3) to receive single dose of 3
      formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads;
      Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation)
      without food. Each period will be separated by a wash out period (no treatment) of at least 1
      week. Part 2 is randomized and 2-way cross-over part of the study. Participants in Part 2
      will be randomly assigned 1 of 2 treatment sequences (Period 1 and Period 2) to receive
      single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 without food
      and with food separated by a wash out period of at least 1 week. Part 3 is single-arm
      sequential (carried out in a staged approach) part of the study. Participants in Part 3 will
      receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 on two
      occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with
      food. Safety will be evaluated by the assessment of adverse events, vital signs, physical
      examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored
      throughout the study. The total duration of study participation for a participant will be 8
      weeks.
    

Intervention name(s): JNJ-40411813: Formulation A; JNJ-40411813: Formulation B; JNJ-40411813: Formulation C; Ketoconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-40411813 100 mg hard gelatin capsule orally (by mouth) as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3.; Participants will receive JNJ-40411813 100 mg immediate release tablet orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3.; Participants will receive JNJ-40411813 100 mg nanosuspension orally as a single dose for Part 1 (Period 1, Period 2, and Period 3).; Participants will receive ketoconazole 200 mg tablet orally twice daily with food from Day 6 to Day 14 in Part 3.
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Relative Bioavailability; Food effect; JNJ-40411813; Positive allosteric modulator; Solid Dosage Formulation of JNJ-40411813; Ketoconazole