A single-center, randomized, investigator/subject-blind, adaptive single-ascending dose (Part 1) and multiple-ascending dose (Part 2), placebo-controlled, parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6889450 following oral administration in healthy subjects.
Completed
- Conditions
- mental disorder characterized by abnormal social behavior and failure to recognize what is real10039628
- Registration Number
- NL-OMON44416
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
healthy male or female volunteers
18 - 45 years, inclusive
BMI 18 - 30 kilogram/meter2, 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 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>Part 1 SAD:<br /><br>To assess the safety and tolerability of RO6889450 after single oral ascending<br /><br>doses.<br /><br><br /><br>Part 2 MAD:<br /><br>To assess the safety and tolerability of RO6889450 after multiple oral<br /><br>ascending doses.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1 SAD:<br /><br>To investigate the pharmacokinetics of RO6889450 in plasma and urine after<br /><br>single oral ascending doses.<br /><br>To investigate the effect of RO6889450 on pharmacodynamic (PD) parameters after<br /><br>single oral ascending doses<br /><br><br /><br>Part 2 MAD:<br /><br>To investigate the pharmacokinetics of RO6889450 in plasma and urine after<br /><br>multiple oral ascending doses (and its metabolite(s) if appropriate).<br /><br>To investigate the effect of RO6889450 on PD parameters after multiple oral<br /><br>ascending doses.</p><br>