Gastrointestinal behavior of abirateronacetaat in healthy volunteers
Phase 1
- Conditions
- healthy volunteers (administration of an androgen synthesis inhibitor)Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2013-005594-51-BE
- Lead Sponsor
- KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
healthy volunteers
age between 18 and 35
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
pregnancy
disease
use of medication
regular exposure to X-radiation last year
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the gastrointestinal behavior and absorption of abirateronacetate.;Secondary Objective: To compare fasted versus fed state.;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