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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-011 | Other Identifier | Cougar Biotechnology, Inc. |
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The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function.
This is an open-label (identity of assigned study drug will be known) pharmacokinetics and safety study of abiraterone acetate administered as four 250 mg tablets (1000 mg) to 3 cohorts (groups) in Cohort 1 (Mild Hepatic Impairment), Cohort 2 (Moderate Hepatic Impairment) and Cohort 3 (Normal Hepatic Function). There will be approximately 8 Participants per cohort (total of approximately 24 Participants for the study). The cohorts will be dosed sequentially and activities will consist of Screening, Study and Follow-up periods, a total of up to approximately 36 days. Possible Participants will be screened to assess their eligibility to enter the study within 14 days prior to study Day 1. Participants will be confined at the Clinical Research Center (CRC) from the time of Check-in on Day -1 until discharge on Day 5. Participants will return to the CRC on Days 8 and 15 and there will be a follow-up call or visit on Day 22. A review of all clinical and laboratory data through Day 8 evaluations in each cohort will be done by the Medical Monitor and the Principal Investigator (PI) prior to proceeding with dosing any further cohort, if indicated. Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Mild Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. |
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| Cohort 2 | Experimental | Moderate Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. |
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| Cohort 3 | Experimental | Normal Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | On the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of abiraterone acetate | Up to 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| The number of Participants with adverse events | Approximately 36 days |
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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 |
| 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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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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