Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01588782 | A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men | PHASE1 | COMPLETED | 20 | — | — | Jan 1, 2012 | Feb 1, 2012 | Nov 27, 2012 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Abiraterone acetate | EXPERIMENTAL | All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. |
| Name | Type | Description |
|---|---|---|
| Period 1: Abiraterone | DRUG | 1000 mg abiraterone acetate tablet administered orally on Day 1 |
| Period 2: Abiraterone/Ketoconazole | DRUG | 400 mg ketoconazole tablets administered orally on Days 11 to 16 |
Inclusion Criteria: \- Body mass index (BMI) between 18 and 30 kg/m2, inclusive Exclusion Criteria: \- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including an...