A Phase 1 interventional study of Abiraterone acetate (Treatment A) and Abiraterone acetate (Treatment B) in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 1, Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 2 and Treatment C (new composition, 2\*500 mg coated tablets) in Period 3.
Drug: Abiraterone acetate (Treatment A) · Drug: Abiraterone acetate (Treatment B)
Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 1, Treatment C (new composition, 2\*500 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 3.
Drug: Abiraterone acetate (Treatment A) · Drug: Abiraterone acetate (Treatment B)
Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2\*500 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 2 and Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 3.
Drug: Abiraterone acetate (Treatment A) · Drug: Abiraterone acetate (Treatment B)
Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 1, Treatment C (new composition, 2\*500 mg coated tablets) in Period 2 and Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 3.
Drug: Abiraterone acetate (Treatment A) · Drug: Abiraterone acetate (Treatment B)
Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 2 and Treatment C (new composition, 2\*500 mg coated tablets) in Period 3.
Drug: Abiraterone acetate (Treatment A) · Drug: Abiraterone acetate (Treatment B)
Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2\*500 mg coated tablets) in Period 1, Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 3.
Drug: Abiraterone acetate (Treatment A) · Drug: Abiraterone acetate (Treatment B)
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.
Also known as: JNJ-212082
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.
Also known as: JNJ-212082
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.
Also known as: JNJ-212082
Maximum Plasma Concentration (Cmax) of abiraterone acetate
The Cmax is the maximum observed plasma concentration of abiraterone acetate.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of abiraterone acetate
The AUC (0-last) is the area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC [0-infinity]) of abiraterone acetate
The AUC (0-infinity) is the area under the plasma abiraterone acetate concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Time to Reach the Maximum Plasma Concentration (Tmax) of abiraterone acetate
The Tmax is the time to reach the maximum observed plasma concentration of abiraterone acetate.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC, ext) of abiraterone acetate
Percentage of area under the plasma abiraterone acetate concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC, ext) is calculated using formula: ((AUC \[0-infinity\] minus- AUC \[0-last)\]/AUC \[0-infinity\])\*100.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Elimination Half-Life (t 1/2, Lambda) of abiraterone acetate
Elimination half-life (t 1/2, Lambda) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Rate Constant (Lambda [z]) of abiraterone acetate
Lambda (z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Time to Last Quantifiable Plasma Concentration (T [last]) of abiraterone acetate
Time to last quantifiable plasma concentration of abiraterone acetate will be observed.
Time frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening up to follow-up (5 to 7 days after last dose administration)
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC