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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR1007 | Other Identifier | Janssen Research & Development, LLC |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ABC) | Experimental | 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. |
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| Sequence 2 (BCA) | Experimental | 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. |
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| Sequence 3 (CAB) | Experimental | 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. |
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| Sequence 4 (ACB) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate (Treatment A) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of abiraterone acetate | The Cmax is the maximum observed plasma concentration of abiraterone acetate. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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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.
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| Sequence 5 (BAC) | Experimental | 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. |
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| Sequence 6 (CBA) | Experimental | 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. |
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| Abiraterone acetate (Treatment B) | Drug | 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. |
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| Abiraterone acetate (Treatment B) | Drug | 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. |
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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. |
| 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). | 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. | 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. | 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. | Screening up to follow-up (5 to 7 days after last dose administration) |
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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