A Study Designed to Evaluate the Pharmacokinetic Profile of Abiraterone
- Registration Number
- NCT04295161
- Lead Sponsor
- Zentiva, k.s.
- Brief Summary
A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 33
Inclusion Criteria
- 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
Exclusion Criteria
- 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 1. 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Prototype 1 Abiraterone Acetate - Reference Abiraterone Acetate - Prototype 2 Abiraterone Acetate - Prototype 4 fasted Abiraterone Acetate administered in fasted state Prototype 3 Abiraterone Acetate - Prototype 4 fed Abiraterone Acetate Administered in fed state
- Primary Outcome Measures
Name Time Method Abiraterone Cmax 24h maximal concentration of abiraterone in human plasma
Abiraterone AUC 24h total exposure up to 24h of abiraterone in human plasma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Ruddington, United Kingdom