Clinical trials: Abiraterone Acetate
Metastatic Castration Resistant Prostate Cancer
Abiraterone Acetate in Combination With Tildrakizumab
The purpose of this study is to find out the side effects and safety of a combination of the anti-IL23 targeting monoclonal antibody tildrakizumab in combination with abiraterone acetate in men with metastatic castration…
- Trial name
- ACTIon (NCT04458311)
- Testing
- Abiraterone Acetate, Tildrakizumab
- Where
- 6 sites in Switzerland, United Kingdom
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Institute of Cancer Research, United Kingdom
Healthy
A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants
The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone…
- Trial name
- NCT01655147
- Testing
- Abiraterone acetate, Rifampicin
- Where
- Belgium
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets.
- Trial name
- NCT04863105
- Testing
- Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Renal Insufficiency
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal…
- Trial name
- NCT01715259
- Testing
- Abiraterone acetate: participants with end-stage renal disease, Abiraterone acetate: matched control participants with normal renal function
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Healthy
Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated…
- Trial name
- NCT02230046
- Testing
- Abiraterone acetate (Treatment A), Abiraterone acetate (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men
The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.
- Trial name
- NCT01588782
- Testing
- Period 1: Abiraterone, Period 2: Abiraterone/Ketoconazole
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Abiraterone Acetate, Gene Polymorphism
Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults
1. To explore the relationship between the changes of plasma concentration of abiraterone acetate after taken orally on fasting or postprandial and gene polymorphism. 2.
- Conditions
- Abiraterone Acetate, Gene Polymorphism, Pharmacokinetic, Metabolic Analysis
- Trial name
- NCT04735913
- Testing
- Abiraterone acetate tablets
- Where
- China
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Zhongnan Hospital
Healthy Volunteers
A Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Participants
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.
- Trial name
- NCT01873001
- Testing
- Pioglitazone HCl, Abiraterone acetate
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients
The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.
- Trial name
- NCT01798628
- Testing
- Treatment A: abiraterone acetate, Treatment B: abiraterone acetate, Treatment C: abiraterone acetate
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Healthy Volunteers
A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants
The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.
- Trial name
- NCT01897389
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Participants
A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial…
- Trial name
- NCT01640093
- Testing
- Abiraterone acetate, 250 mg (uncoated, current commercial tablet), Abiraterone acetate, 500 mg (coated, reformulated tablet), Abiraterone acetate, 250 mg (coated, reformulated tablet)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
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…
- Trial name
- NCT01678573
- Testing
- Treatment A: abiraterone acetate, Treatment B: abiraterone acetate, Treatment C: abiraterone acetate
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation in Healthy Adult Volunteers
The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet…
- Trial name
- NCT01362764
- Testing
- Abiraterone acetate suspension Formulation 1, Abiraterone acetate suspension Formulation 2, Abiraterone acetate tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Pharmacology
A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men
The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.
- Trial name
- NCT01575587
- Testing
- Abiraterone: Treatment A, Abiraterone: Treatment B, Abiraterone: Treatment C
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC