Measuring concentrations of the drug atazanavir along the gastrointestinal tract in human subjects after oral administration of the drug product
Phase 1
- Conditions
- Healthy human volunteersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2017-004579-29-BE
- Lead Sponsor
- KU Leuven Drug Delivery & Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
-Healthy 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
- Disease
- Acute/chronic GI condition
- Use of medication
- Pregnancy
- frequent exposure to X-rays during the past year
- HIV / HBV / HCV infection
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 investigatie principles of supersaturation and<br>precipitation of a weakly basic drug atazanavir along the gastrointestinal tract in healthy human volunteers. The influence of acidic and calory-containing beverages will also be investigated.;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