A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
      medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet
      formulations compared with the current commercial abiraterone acetate tablet formulation in
      healthy male participants, under fasted conditions, at a single dose of 1000 mg.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      study medication is assigned by chance), single-center, 4-way crossover study (method used to
      switch participants from one treatment arm to another in a clinical trial) of a single dose
      of abiraterone acetate (1000 mg). The study will consist of 3 phases including screening
      phase (of 21 days), an open-label treatment phase consisting of 4 single-dose treatment
      periods, and follow-up phase. All participants will be randomly assigned to 1 of 4 possible
      treatment sequences to ensure that they receive all of the following treatments, one in each
      period. The 4 sequences are as follows: Sequence 1: Treatment A, D, B, and C; Sequence 2:
      Treatment B, A, C, and D; Sequence 3: Treatment C, B, D, and A; and Sequence 4: Treatment D,
      C, A, and B. After a washout period of 7 days, follow-up phase will occur between 5 to 7 days
      after the last study procedure. The duration of participation in the study for each
      participant is from 47 days to a maximum of 68 days (including screening). Pharmacokinetics
      will be measured by collection of blood samples. Participants will be confined to the study
      center until completion of the 96 hour pharmacokinetic assessments on Day 5 of each treatment
      period. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram,
      vital signs, and physical examinations will be monitored throughout the study.
    

Intervention name(s): Abiraterone acetate, 250 mg (uncoated, current commercial tablet); Abiraterone acetate, 500 mg (coated, reformulated tablet); Abiraterone acetate, 250 mg (coated, reformulated tablet); Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.; Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.; Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.; Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.
Other intervention name(s): ZYTIGA; ZYTIGA; ZYTIGA; ZYTIGA
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Bioavailability; Pharmacokinetics; Abiraterone acetate; Abiraterone