A Phase 1 interventional study of Cohort 1 and Cohort 2 in Hepatic Impairment, sponsored by Janssen Research & Development, LLC. Completed at 3 sites in United States. Open to male participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation.
This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 2-cohort study of abiraterone acetate in approximately 16 adult men. Participants will either have severe hepatic impairment (Cohort 1) or qualify for the control group with normal hepatic function (Cohort 2). This study will consist of a screening period followed by a 4-day open-label treatment phase and subsequently a 28-day follow up after the study dose of abiraterone acetate suspension. Patients will be admitted to the study center on Day -1, a single dose of study drug will be administered on the morning of Day 1, and patients will remain at the study center until completion of the 72-hour pharmacokinetic (PK; study of what the body does to a drug) blood sample collection in the morning of Day 4. Enrollment will begin sequentially with patients in the severe hepatic impairment cohort. Enrollment for Cohort 1 will be staggered in order to evaluate safety and tolerability. The study will not proceed if >=Grade 3 toxicity or serious adverse events considered related to abiraterone acetate are observed. Additional patients may be enrolled if at least 8 patients in each cohort do not complete the required assessments, including the PK blood sample collections. The aim will be to treat the remaining patients in Cohort 1 at a suspension dose yielding an exposure equivalent to 1000 mg tablet in healthy individuals. If the dose is adjusted after Study Evaluation Team review, additional patients may be enrolled to ensure at least 8 patients complete the study at the final dose. Once enrollment of patients in the severe hepatic impairment cohort is completed, the matched-control cohort will be dosed. Serial PK samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
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Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Exclusion Criteria:
Patients with severe hepatic impairment.
Drug: Cohort 1
Healthy individuals with normal hepatic function.
Drug: Cohort 2
125 mg to 2000 mg abiraterone acetate suspension on Day 1
2000 mg abiraterone acetate suspension on Day 1
Mean plasma concentrations of abiraterone
Time frame: Up to Day 4
Mean plasma protein binding concentrations of abiraterone
Time frame: Screening Day -2
Maximum plasma concentrations of abiraterone
Time frame: Up to Day 4
Time to reach the maximum plasma concentration of abiraterone
Time frame: Up to Day 4
Area under the plasma concentration-time curve from time 0 to 24 hours after dosing of abiraterone
Time frame: Up to Day 4
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone
Time frame: Up to Day 4
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time frame: Up to Day 4
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Time frame: Up to Day 4
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Time frame: Up to Day 4
Time to last quantifiable plasma concentration of abiraterone
Time frame: Up to Day 4
Total apparent clearance of drug after extravascular administration uncorrected for absolute bioavailability of abiraterone
Time frame: Up to Day 4
Apparent volume of distribution after extravascular administration uncorrected for absolute bioavailability of abiraterone
Time frame: Up to Day 4
The number of participants affected by an adverse event
Time frame: Up to Day 29
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC