An open label, single oral dose study to investigate the pharamcokinetics - absorption, distribution, metabolism, and elimination - of 75 mg of 14C-labeled BCT197 in healthy male volunteers.
Completed
- Conditions
- chronic infection of the lungschronic obstructive pulminonary disease10006436
- Registration Number
- NL-OMON36837
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
Healthy male volunteers
18-45 years, inclusive
BMI: 18-30 kg/m2, inclusive
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 month prior to the start of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics:<br /><br>blood, plasma and skin concentrations of radioactivity<br /><br>plasma and skin concentrations of BCT197<br /><br>metabolite patterns in plasma and skin<br /><br>excretion of radioactivity, metabolite patterns in urine and feces<br /><br><br /><br>Pharmacogenetics<br /><br><br /><br>Safety: adverse events, vital signs, ECG, clinical laboratory and physical<br /><br>examination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>