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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR1010 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.
This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 4-period, 5-treatment crossover study in order to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation. Approximately 32 healthy adult males will participate. The total study length is up to 68 days. This study will consist of a screening phase followed by an open-label treatment phase consisting of 4 single-dose treatment periods separated by a washout period of at least 7 days between dosing. Individuals will be randomly assigned to 1 of 8 treatment sequences. A single dose of 1000 mg abiraterone acetate will be given in each treatment period under fasted conditions. Participants will be confined to the study center from Day -1 of each treatment period until completion of the 96-hour blood sample collection on Day 5 of each treatment period. A follow-up visit will occur between 5 to 7 days after the last study procedure. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: abiraterone acetate | Experimental | Treatment sequence 1 is defined as: AEBD |
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| Sequence 2: abiraterone acetate | Experimental | Treatment sequence 2 is defined as: BACE |
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| Sequence 3: abiraterone acetate | Experimental | Treatment sequence 3 is defined as: CBDA |
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| Sequence 4: abiraterone acetate | Experimental | Treatment sequence 4 is defined as: EDAC |
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| Sequence 5: abiraterone acetate | Experimental | Treatment sequence 5 is defined as: DECA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | 1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h | |
| Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h | |
| Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h | |
| Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h | |
| Time to reach the maximum plasma concentration of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h | |
| First-order rate constant associated with the terminal portion of the drug-concentration-time curve of abiraterone |
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 |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Sequence 6: abiraterone acetate | Experimental | Treatment sequence 6 is defined as: EADB |
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| Sequence 7: abiraterone acetate | Experimental | Treatment sequence 7 is defined as: ABEC |
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| Sequence 8: abiraterone acetate | Experimental | Treatment sequence 8 is defined as: BCAD |
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| Treatment B | Drug | 1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions |
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| Treatment C | Drug | 1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions |
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| Treatment D | Drug | 1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions |
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| Treatment E | Drug | 1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions |
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| Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h |
| Time to last quantifiable plasma concentration of abiraterone | Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h |