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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR1011 | Other Identifier | Janssen Research & Development, LLC | |
| 2013-001408-12 | EudraCT Number |
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The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone acetate in healthy adult male participants.
This is an open-label (identity of assigned study drug will be known) single-dose drug-drug interaction study to assess the effect of abiraterone on pioglitazone. Approximately 16 healthy adult male participants will be enrolled in this study. The study consists of a screening phase, an open-label treatment phase consisting of 2 single-dose treatment periods, end-of-study or withdrawal assessments done upon completion of the 72-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal, and a follow-up visit 5 to 7 days after the last study procedure. The total study length is 32 days. Participants will receive pioglitazone alone on Day 1 (Period 1) of the study. On Day 8 (Period 2), participants will receive a single dose of abiraterone acetate followed by a single dose of pioglitazone one hour later. Successive pioglitazone administrations will be separated by a washout period of 7 days. Participants will be confined to the study center from Day -1 to Day 4 of Period 1 and from Day 7 to Day 11 of Period 2, at least 10 hours before each study drug administration until completion of the 72-hour blood sample collection for each period. A pharmacogenomic blood sample will be collected from all participants on Day -1. Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate + pioglitazone HCl | Experimental | Participants will receive 15 mg pioglitazone on Day 1 (Period 1). On Day 8 (Period 2), participants will receive 1000 mg abiraterone acetate followed by 15 mg of pioglitazone one hour later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone HCl | Drug | 15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Time to reach the maximum observed plasma concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Area under the plasma concentration-time curve from time 0 to infinite time of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Percentage of area under the plasma concentration time curve obtained by extrapolation of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Time to last observed quantifiable plasma concentration of pioglitazone | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h | |
| Time to reach the maximum observed plasma concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
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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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| Abiraterone acetate | Drug | 1000 mg tablets administered by mouth on Day 8 |
|
| Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Percentage of area under the plasma concentration-time curve obtained by extrapolation of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Time to last observed quantifiable plasma concentration of abiraterone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Apparent total plasma clearance of drug after extravascular administration of pioglitazone | Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Metabolite to parent drug ratio for maximum observed plasma concentration | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time | Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h |
| Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) | Up to 30 days after the last dose of study medication |
| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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