A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations

Zentiva, k.s.1 个研究点分布在 1 个国家目标入组 33 人开始时间: 2019年6月25日最近更新: 2020年3月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Zentiva, k.s.
入组人数: 33
试验地点: 1
主要终点: Abiraterone Cmax

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations

详细描述

This was a single centre, 2 part, open-label study in healthy male subjects. Parts 1 and 2 were conducted in separate cohorts of subjects; subjects were not permitted to participate in both parts. Part 1 was a part-randomised, 4 period crossover study planned to include 24 healthy male subjects. Part 2 was a randomised 2-period crossover study in 12 healthy male subjects. The aim was to evaluate the pharmacokinetic profiles of abiraterone following administration of immediate release prototype formulations in healthy male subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy males
•Age 18 to 55 years of age at the time of signing informed consent
•Expressed a desire not to father children in the near future (within 6 months of last IMP dose); males under 40 years of age must have been vasectomised
•Body mass index (BMI) of 18.5 to 30.0 kg/m2 as measured at screening
•Willing and able to communicate and participate in the whole study
•Provided written informed consent
•Agreed to adhere to the contraception requirements defined in Section 9.4 of the protocol

排除标准

•Subjects who received any IMP in a clinical research study within the 3 months or 90 days prior to Day 1 Period 1
•Males with a pregnant female partner
•Subjects were unable or unwilling to consume the standard high-fat breakfast (Part 2)
•Subjects were study site employees, or immediate family members of a study site or sponsor employee
•Subjects who had previously been enrolled in this study. Subjects who had taken part in Part 1 were not permitted to take part in Part 2
•History of any drug or alcohol abuse in the past 2 years prior to screening
•Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type) as confirmed by a repeat of the first positive alcohol breath test at screening or admission
•Current smokers and those who had smoked within the last 12 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm, as confirmed by repeat of the first test at screening or admission
•Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months prior to screening
•Subjects without suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
•Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator
•Serum potassium below the lower limit of the laboratory reference range at screening
•Alanine aminotransferase >1.5× upper limit of laboratory reference range at screening
•Total bilirubin >1.5× upper limit of laboratory reference range at screening
•Confirmed positive drugs of abuse test result
•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) orhuman immunodeficiency virus (HIV) results at screening
•Systolic blood pressure (BP) >140 mmHg, diastolic blood pressure >90 mmHg (systolic blood pressure up to 150 mmHg allowed in subjects >45 years of age) at screening or Period 1 Day 1 pre-dose
•History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
•Subjects with a history of cholecystectomy or gall stones
•Serious adverse reaction or serious hypersensitivity to any drug
•History of any hypersensitivity reaction to abiraterone or the formulation excipients regardless of severity
•Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, lactose intolerance
•Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active
•Donation or loss of greater than 400 mL of blood within the previous 3 months prior to screening
•Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other than 4 g of paracetamol per day) or herbal remedies in the 14 days before Day 1, Period
•Exceptions may have been applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI
•Use of known strong CYP3A4 inducers, including St John's Wort, in the 30 days prior to Period 1 Day 1
•Failure to satisfy the investigator of fitness to participate for any other reason