A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 3 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Abiraterone acetate, 500 mg (coated, reformulated tablet)
- Conditions
- Healthy Participants
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 32
- Primary Endpoint
- Maximum plasma concentration (Cmax) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have body weight not less than 50 kg
- •Must be a non-smoker, and has no history of smoking or use of nicotine-containing substances within the previous 2 months
- •Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- •Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
- •Must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study for 3 months after receiving the last dose of study medication
Exclusion Criteria
- •History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease that could interfere with the interpretation of the study results
- •Clinically significant abnormal values for hematology or urinalysis (at screening)
- •Clinically significant abnormal physical examination vital signs or 12-lead electrocardiogram (at screening)
- •Usage of any prescription or nonprescription medication, except for acetaminophen, and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study medication is scheduled
- •Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study medication)
Arms & Interventions
Treatment B
Abiraterone acetate (500 mg), 2 coated, reformulated tablets.
Intervention: Abiraterone acetate, 500 mg (coated, reformulated tablet)
Treatment C
Abiraterone acetate (250 mg), 4 coated, reformulated tablets.
Intervention: Abiraterone acetate, 250 mg (coated, reformulated tablet)
Treatment D
Abiraterone acetate (500 mg), 2 coated, reformulated tablets, showing slower in vitro dissolution.
Intervention: Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)
Treatment A
Abiraterone acetate (250 mg), 4 uncoated, current commercial tablets.
Intervention: Abiraterone acetate, 250 mg (uncoated, current commercial tablet)
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
Time Frame: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours
Pharmacokinetic parameter Cmax of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
Area under the plasma concentration versus time curve (AUC) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet
Time Frame: For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours
Pharmacokinetic parameter AUC of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
Secondary Outcomes
- Number of participants with adverse events(Up to 68 days)