Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic
      parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current
      commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or
      drinking) conditions in healthy male participants.
    

Detailed description: 
      This is a Phase 1, randomized (study medication assigned to participants by chance),
      open-label (all people know the identity of the intervention), single-center, single-dose and
      3-way Crossover (the same medications provided to all participants but in different sequence)
      pivotal study to determine the bioequivalence of 2 abiraterone acetate coated tablet
      formulations with respect to the current commercial abiraterone acetate uncoated tablet
      formulation. Approximately 102 healthy male participants will participate in this study.
      Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist
      of 3 parts: Screening Phase (within 21 days before the first study drug administration of the
      first period), an open-label treatment Phase consisting of 3 single-dose treatment periods
      (45 days) and follow-up Phase (5 to 7 days after the last study procedure). The total study
      duration for each participant will be from 45 days to a maximum of 61 days. Participants will
      receive a single oral 1000 milligram (mg) dose of abiraterone acetate under fasted conditions
      either as Treatment A (current commercial formulation, uncoated), Treatment B (current
      commercial formulation, coated) or Treatment C (new composition, coated). Bioequivalence will
      be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Abiraterone acetate (Treatment A); Abiraterone acetate (Treatment B); Abiraterone acetate (Treatment B)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.; Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.; Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
Other intervention name(s): JNJ-212082; JNJ-212082; JNJ-212082
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy,; Abiraterone Acetate,; Bioequivalence.