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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-009 | Other Identifier | Cougar Biotechnology, Inc. |
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The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.
This is an open-label (identity of assigned study drug will be known), randomized (treatment sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg administered orally (by mouth) in approximately 36 healthy male participants under fasted and fed conditions. Three doses of abiraterone acetate will be administered with a 7-day washout period between each dose. The total study duration for each participant will be 21 days. Participants will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA): Treatment A = abiraterone acetate 1000 mg administered after a high-fat meal; Treatment B = abiraterone acetate 1000 mg administered after a low-fat meal; Treatment C = abiraterone acetate 1000 mg administered in the fasted state. No food will be ingested for 4 hours post-dose. Participants will be confined at the clinical research unit from the day prior to dosing until clinic discharge on the day following dosing in each treatment period. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental |
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| Sequence ACB | Experimental |
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| Sequence BAC | Experimental |
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| Sequence BCA | Experimental |
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| Sequence CAB | Experimental |
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| Sequence CBA | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: abiraterone acetate | Drug | 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of abiraterone | Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose | |
| Time to maximum concentration of abiraterone | Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose | |
| Area under the concentration-time curve from time 0 to the last measurable concentration of abiraterone | Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose | |
| Area under the concentration-time curve extrapolated to infinity of abiraterone | Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose | |
| Apparent plasma terminal elimination rate constant of abiraterone | Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose | |
| Apparent terminal elimination half-life of abiraterone | Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants affected by an adverse event | Up to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cougar Biotechnology, Inc. Clinical Trial | Cougar Biotechnology, Inc. | Study Director |
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| Treatment B: abiraterone acetate | Drug | 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal |
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| Treatment C: abiraterone acetate | Drug | 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state |
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