NCT04735913

Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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. Study of drug Metabolite profiling after oral administration of abiraterone acetate on fasting and postprandial in Chinese adults.

Detailed description

Prostate cancer is the most common malignancy in men currently, second only to lung cancer in China. And in Europe and America, it has already overtaken lung and bowel cancer and become the greatest threat of of men's health. After the diagnosis of high-risk prostate cancer patients, endocrine therapy is still the main treatment. It is effective for most patients who receive androgen deprivation therapy at first. However, after the remission whose median time is 18 to 24 months through endocrine therapy, most patients will turn to castration resistant prostate cancer (CRPC). The treatment of CRPC has always been a difficult point , and now it has become the emphasis of new endocrine drug development for prostate cancer. Abiraterone acetate tablets in combination with prednisone apply to the treatment of metastatic castration-resistant prostate cancer. It has been approved by the US Food and Drug Administration in 2011 and gotten listing license in China. Abiraterone acetate is an effective irreversible inhibitor CYP17 enzyme and can be converted into abiraterone in vivo. Abiraterone is an androgen biosynthesis inhibitor with a high affinity and selectivity to CYP17. The inhibitory activity of abiraterone for CYP17 was 10-30 times higher than that of ketoconazole. Androgen biosynthesis is inhibited by inhibiting CYP17. The results of many large-scale clinical trials showed that abiraterone acetate could effectively prolong survival time of the patients . In this study, Blood and plasma samples, urine and faeces samples in 72h from healthy Chinese adult volunteers who have taken abiraterone acetate tablet orally on an empty stomach or after meals were collected for metabolite analysis, the relationship between plasma concentration and gene polymorphism, and identifying the major metabolites in metabolic biological samples to reveal the pharmacokinetic characteristics of abiraterone acetate tablets，demonstrate the pharmacodynamic mechanism，and explore the effect of different genotypes Pharmacokinetic characteristics in healthy Chinese adults. The result provides theoretical basis for clinical rational drug use.

Conditions

• Abiraterone Acetate
• Gene Polymorphism
• Pharmacokinetic
• Metabolic Analysis
• Plasma Concentration

Interventions

Type	Name	Description
DRUG	Abiraterone acetate tablets	Subjects will take abiraterone acetate tablets (250 mg, produced by Patheon Ich, trade name: Zytiga®) orally on an empty stomach or after meals and their blood and plasma samples, urine and faeces samples in 72h will be collected for detection.

Timeline

• Start date: 2020-05-05
• Primary completion: 2020-08-20
• Completion: 2022-07-01
• First posted: 2021-02-03
• Last updated: 2022-01-03

Locations

1 site across 1 country: China