A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of LEE011 after a single oral dose of 600 mg [14C]LEE011 (0.37 MBq) in healthy male subjects
Completed
- Conditions
- gevorderde kankeradvance cancer
- Registration Number
- NL-OMON40904
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male subjects
45 - 65 yrs, inclusive
BMI: 18.0 - 30.0 kg/m2, inclusive
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 0.4 liters of blood in the 8 weeks 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]LEE011 related<br /><br>radioactivity, including mass balance of total drug-related radioactivity in<br /><br>urine and feces, following the oral administration of a single 600 mg dose of<br /><br>[14C]LEE011 to healthy male subjects.<br /><br>* To determine the pharmacokinetics of total radioactivity in blood and in<br /><br>plasma.<br /><br>* To characterize the plasma pharmacokinetics of LEE011 and known key<br /><br>metabolites, if applicable.<br /><br>* To characterize the urine concentrations of LEE011 and known key metabolites,<br /><br>if applicable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To assess the safety of a single 600 mg oral dose of [14C]LEE011 administered<br /><br>to healthy male subjects.</p><br>