Status:
COMPLETED
A Study Designed to Evaluate the Pharmacokinetic Profile of Abiraterone
Lead Sponsor:
Zentiva, k.s.
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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. Par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04295161
Start Date
June 25 2019
End Date
November 8 2019
Last Update
March 4 2020
Active Locations (1)
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1
Quotient Sciences
Ruddington, United Kingdom