A single-center, randomized, double-blind, adaptive, parallel study to investigate the safety, tolerability, pharmacokinetics (Including the effect of food), and pharmacodynamics of RO6806127 in healthy male subjects.
Completed
- Conditions
- personality disorder10039628
- Registration Number
- NL-OMON41129
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 93
Inclusion Criteria
Healthy male subject
18 and 45 years of age, inclusive
BMI 18 - 30 kilograms/meter2
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>Primary: To assess the safety and tolerability of single ascending oral doses<br /><br>of RO6806127 in healthy male subjects and to determine, if achievable, the<br /><br>maximum tolerated dose (MTD).<br /><br>To investigate the single-dose oral pharmacokinetics (PK) of RO6806127 and its<br /><br>metabolite(s) as appropriate, in plasma and urine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1 Secondary:<br /><br>To screen for the presence of metabolites of RO6806127 in selected plasma and<br /><br>urine samples.<br /><br>To explore the relationship between exposure of RO6806127 and<br /><br>tolerability/pharmacodynamics.<br /><br><br /><br>Part 2: Food Effect (FE) Study<br /><br>Secondary: To assess the effect of high fat and high caloric food on the<br /><br>relative bioavailability of a single oral dose of RO6806127<br /><br>administered to healthy male subjects.</p><br>