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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhongnan Hospital
• Treatments: Abiraterone Acetate

Criteria

Inclusion Criteria:

• Age: Healthy male subjects aged 18 to 65 years

• Weight: weight ≥50.0kg, 19 ≤ BMI ≤ 26 kg/m2, BMI=weight (kg) / height2(m2)

• Fully aware of the purpose, nature, method and possible adverse reactions of the study, and sign informed consent prior to the commencement of any study procedure on a voluntarily base.

• Be able to communicate well with the investigator and understand and abide by the terms of the study requirements.

Exclusion Criteria:

• Clinical laboratory examination is abnormal and clinically significant.

• Vital signs examination is abnormal and clinically significant, or there are other diseases of clinical significance（Including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio-cerebrovascular disease）or other specific systemic disease.

• Electrocardiogram is abnormal and clinically significant.

• HbsAg, Anti - HCV, TPPA, or HIV antibody positive.

• History of allergy to abiraterone acetate tablets or its ingredients and analogs

• The number of daily smoking >5 during 3 months before the trial.

• Alcoholics or regular drinkers in the 6 months prior to the trial, that is drinking more than 14 units per week (1 Unit =360mL beer or 45mL 40% liquor or 150mL wine)

• Positive for drug, has a history of drug abuse in the past five years or has used drugs in the 3 months prior to the trial.

• Positive for alcohol screening or use of any alcoholic product within 24 hours prior to taking the study drug.

• Blood donation or massive blood loss within 3 months prior to taking the study drug (>450mL).

• Take any xanthine rich beverage, food, grapefruit fruit or products that contain grapefruit in 48 hours before the trial.

• Take in chocolate or any food or drink containing caffeine in 48 hours before the trial.

• A history of dysphagia or any gastrointestinal disease that affect drug absorption.

• Have taken the study drug or participated in the drug or medical device within three months before this trial.

• There are major changes in diet or exercise habits recently.

• Acute disease occurs during the study screening phase or prior to taking study drugs.

• There are drug combination of CYP3A4, P-GP, or Bcrp inhibitors or inducers (such as itraconazole, ketoconazole, dronedarone et al.), or any drugs that affect hepatic microsomal enzyme activity during the 28 days before taking the study drug.

• Accompanied by any coagulation disorders (such as Willebrand's disease or hemophilia) or history of hemorrhagic disease.

• Accompanied by any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, stomach or duodenal ulcers, etc.

• Special requirements on diet and fails to comply with the diet provided and the corresponding regulations, especially for the lactose intolerant.

• History of asthma or seizures.

• Have a pregnancy plan in 6 months, sperm or egg donation, or reluctance to use one or more non-drug contraceptives during the trial.

• Taking any prescription drugs, nonprescription drug, over-the-counter, vitamin products, or herbal medicines in 14 days before taking the study drug.

• Patients with abnormal nucleic acid or antibody detection of COVID-19 and considered ineligible by the investigator.

• Pulmonary CT were abnormal and considered inappropriate to participate in the study by the investigator.

• Subjects considered to have poor compliance or have any factors that would make them inappropriate to participate in the study.