Clinical trial · Interventional
A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
A Phase 1 Single Dose Open-Label Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
NCT02001571CI-TRIAL-00012890completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Mild Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.
- interventionNames
- Drug: Abiraterone acetate
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Moderate Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.
- interventionNames
- Drug: Abiraterone acetate
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Normal Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Non smokers or light smokers and willing to limit smoking for the period of confinement to 4 cigarettes per day * Body Mass Index of 18-35 kg/m2 * Negative test for breathalyzer alcohol and drugs of abuse and HIV antibody test at Screening * Agrees to protocol-defined use of effective contraception * Participants with Mild or Moderate Hepatic Impairment * Must have mild or moderate hepatic impairment * On a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study * Clinical laboratory evaluations within the reference range for the test laboratory * Participants with normal hepatic function have no clinically significant findings from medical history, physical examination, Laboratory values within protocol defined parameters Exclusion Criteria: * Any other investigational study drug trial within 5 half-lives of that investigational study drug or 30 days prior to dosing with Abiraterone acetate, whichever is longer * Inability to swallow four (4) 250 mg abiraterone acetate tablets * History of or current clinically significant medical illness that would potentially alter absorption and/or excretion of orally administered drugs * History or presence of a clinically significant abnormal ECG * Donation of blood or significant loss of blood within 56 days prior to Day 1 or planned donation of blood or plasma from Screening through 30 days after Day 1 * Use of any prescription medications/products or any OTC, non-prescription unrelated to existing allowable stable medical conditions within 5 half-lives of that product or 7 days prior to dosing with abiraterone acetate, whichever is longer * Clinically significant renal laboratory findings * Participants with Mild or Moderate Hepatic Impairment will be excluded - any significant medical history other than hepatic impairment that may affect the interpretation of the data or which otherwise contraindicates participation in the study * Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 2 weeks * Autoimmune liver disease; Esophageal variceal bleeding within 6 months prior to Screening, unless successfully treated with banding, Gastric varices * Spontaneous bacterial peritonitis within 3 months prior to Screening * Portosystemic shunt, Organ transplant, Wilson's disease, Cholestatic liver disease (e g , primary biliary cirrhosis or primary sclerosing cholangitis) * Clinically significant laboratory findings except as related to hepatic impairment * Control Participants with Normal Hepatic Function Any significant laboratory results, including specifically Positive for Hepatitis B or C, Hemoglobin \< 12 0 g/dL LFTs outside of normal limits
References
Publications (1)
- DERIVEDMarbury T, Lawitz E, Stonerock R, Gonzalez M, Jiao J, Breeding J, Haqq C, Verboven P, Stieltjes H, Yu M, Molina A, Acharya M, Chien C, Tran N. Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment. J Clin Pharmacol. 2014 Jul;54(7):732-41. doi: 10.1002/jcph.253. Epub 2014 Jan 17. PMID 24374856