A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single Ascending-Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.
Completed
- Conditions
- psychiatric disordersSchizofrenia10039628
- Registration Number
- NL-OMON36943
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
Inclusion Criteria
Healthy male subjects
18-45 yrs, inclusive
BMI 18 to 30 kg/m2, inclusive
Light smokers or non-smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
Participation in another drug study within 90 days before screening, as calculated from the day of follow-up from the previous study.
Any donation of blood or significant blood loss within 3 months prior to first administration of the study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamics: Prolactin<br /><br>Pharmacokinetics: plasma/urine drug concentrations<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination, ESRS-A, DSST, Bond & Lader VAS</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>