Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ABI-PRO-1016 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.
This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: abiraterone acetate | Experimental | Randomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "ABC" under fasted conditions. |
|
| Sequence 2: abiraterone acetate | Experimental | Randomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "BAC" under fasted conditions. |
|
| Sequence 3: abiraterone acetate | Experimental | Randomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule "CBA" under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: abiraterone acetate | Drug | 250 mg/day tablet administered orally on Day 1 of each treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of abiraterone | Pre-dose and up to 96 hours post-dose each treatment period | |
| Time to reach the maximum observed plasma concentration of abiraterone | Pre-dose and up to 96 hours post-dose each treatment period | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone | Pre-dose and up to 96 hours post-dose each treatment period | |
| Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone | Pre-dose and up to 96 hours post-dose each treatment period | |
| Apparent terminal elimination rate constant of abiraterone | Pre-dose and up to 96 hours post-dose each treatment period | |
| Apparent terminal elimination half-life of abiraterone | Pre-dose and up to 96 hours post-dose each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 42 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China |
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Treatment B: abiraterone acetate | Drug | 500 mg/day tablets administered orally on Day 1 of each treatment period. |
|
|
| Treatment C: abiraterone acetate | Drug | 1000 mg/day tablets administered orally on Day 1 of each treatment period. |
|
|
| D011083 |
| Polycyclic Compounds |