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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-003490-28 | EudraCT Number |
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The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone acetate tablets in healthy male participants.
This is an open-label (all people know the identity of the intervention), single-center (study conducted at one site), 2-period, sequential-design (studies that combine both longitudinal and cross sectional methods), to evaluate the effects of rifampicin on the pharmacokinetics of abiraterone acetate in healthy male participants. The study consists of a screening phase, an open-label treatment phase, and a follow up phase. The screening phase will be within 14 days before the first study medication administration. The treatment phase will consist of 2 treatment periods, Period 1: a single oral dose of abiraterone acetate tablets, and Period 2: a daily oral dose of rifampicin capsules alongwith a single oral dose of abiraterone acetate tablets. The 2 periods will be separated by a washout period of at least 7 days. Blood sample collection for pharmacokinetic assessments will be done for determination of abiraterone and rifampicin concentrations. The follow up phase will be of 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study. The total study duration will be approximately 31 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate + Rifampicin | Experimental | Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 1 of Period 1. Rifampicin 600 mg (2 x 300 mg) on Days 8 to 13, and Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 14 of Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Type=exact number, unit=mg, number=1,000, form=tablet, route=oral. Abiraterone acetate administered on Day 1 of Period 1, and Day 14 of Period 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2 | Pharmacokinetic parameter Cmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2. | Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 |
| Area under the plasma concentration-time curve (AUC) of abiraterone in Period 1 and Period 2 | Pharmacokinetic parameter AUC of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2. | Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 |
| Time to reach the maximum plasma concentration (tmax) of abiraterone in Period 1 and Period 2 | Pharmacokinetic parameter tmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2. | Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 |
| Eliminaton half-life (t1/2) of abiraterone in Period 1 and Period 2 | Pharmacokinetic parameter t1/2 of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2. | Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 31 days |
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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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Rifampicin | Drug | Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2. |
|
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| D011083 |
| Polycyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |