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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-012 | Other Identifier | Cougar Biotechnology, Inc. |
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The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.
This is an open-label (identity of assigned study drug will be known) pharmacokinetics study evaluating a single dose of abiraterone acetate 1000 mg administered in male participants with end-stage renal disease compared to matched-control (matched for age and body mass index) participants with normal renal function. There will be approximately 8 participants in each cohort (group). The total study duration for each participant will be 36 days. Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate: participants with end-stage renal disease | Drug | abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of abiraterone | Within 0.5 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 plasma concentration of abiraterone | Within 0.5 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 plasma concentration of abiraterone | Within 0.5 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 infinity of abiraterone | Within 0.5 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 | |
| Terminal phase rate constant of abiraterone | Within 0.5 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 | |
| Terminal plasma elimination half-life of abiraterone | Within 0.5 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 | |
| Oral clearance of abiraterone | Within 0.5 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 volume of distribution of abiraterone | Within 0.5 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 22 |
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Inclusion Criteria:
All participants:
Patients with renal impairment must additionally meet the following criteria:
Control participants with normal renal function must additionally meet the following criteria:
- Must be in good health
Exclusion Criteria:
All participants:
Patients with renal impairment who meet any of the following criteria will be excluded from the study:
Control participants with normal renal function who meet any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Cougar Biotechnology, Inc. Clinical Trial | Cougar Biotechnology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24374856 | Derived | Marbury T, Lawitz E, Stonerock R, Gonzalez M, Jiao J, Breeding J, Haqq C, Verboven P, Stieltjes H, Yu M, Molina A, Acharya M, Chien C, Tran N. Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment. J Clin Pharmacol. 2014 Jul;54(7):732-41. doi: 10.1002/jcph.253. Epub 2014 Jan 17. |
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| Abiraterone acetate: matched control participants with normal renal function | Drug | abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1 |
|
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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