SINGLE-CENTER, SINGLE DOSE ORAL EXCRETION BALANCE STUDY OF RO5200628 IN HEALTHY MALE VOLUNTEERS
Completed
- Conditions
- depressionMajor depressive disorder10027946
- Registration Number
- NL-OMON34612
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
1. Age: between18 and 65 years of age;
2. BMI: between 18 and 30 kg/m2;
3. Non-smoker and moderate smokers
Exclusion Criteria
1. History of any clinically significant hematological, hepatic, gastro-intestinal, endocrine, respiratory, cardiovascular, renal, urogenital, central nervous system (CNS), allergic, ophthalmologic disease, metabolic disorder, cancer or cirrhosis.
2. Diseases or surgical or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs or of constituting a risk factor when taking the study drug in the judgment of the investigator.
3. Presence or history of any medically diagnosed, clinically significant psychiatric disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study variable is the urinary and fecal recovery of total<br /><br>radioactivity. </p><br>
- Secondary Outcome Measures
Name Time Method <p>All other kinetic parameters and the safety data will be regarded as secondary.</p><br>