A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of QBW251 following a single oral dose of [14C]QBW251 in healthy male subjects at steady state conditions.
Completed
- Conditions
- ongaandoeningenCOPDlung diseases
- Registration Number
- NL-OMON46062
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male subjects
18 - 55 years of age
weight at least 55 kilograms, and no more than 120 kg
(BMI) 18 - 30 kilograms/meter2
non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the rates and routes of excretion of [14C]QBW251 related<br /><br>radioactivity, including mass balance of total drug-related radioactivity<br /><br>in urine and feces following a single 400 mg oral dose of [14C]QBW251 at steady<br /><br>state in healthy volunteers.<br /><br><br /><br>To determine the pharmacokinetics of total radioactivity in blood and plasma.<br /><br><br /><br>To characterize the plasma pharmacokinetics of QBW251 and known key<br /><br>metabolites, if applicable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of multiple oral doses of 400 mg of<br /><br>QBW251 administered to healthy male subjects</p><br>