De influence of lipid digestion on the drug abiraterone acetate in the small intestine after oral administration to human volunteers
Phase 1
- Conditions
- Healthy human volunteersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2019-003460-50-BE
- Lead Sponsor
- KU Leuven Drug Delivery and Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 5
Inclusion Criteria
Healthy male volunteers
Age between 18 and 40 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Women
Acute/chronic gastrointestinal/liver/cardiac disease
Use of medication (CYP3A4 inductor)
Frequent exposure to X-rays during the past year
HIV/HBV/HCV infection
(Possible) pregnancy of partner
Allergies for excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The study aims to investigate the influence of lipid digestion on abiraterone acetate along the intestinal tract in healthy human volunteers. The study will be conducted in fasted and fed state, with and without inhibition of lipid digestion.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable