A single-center randomized, adaptive, investigator/participant blind, single oral ascending dose, placebo-controlled Phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7189752 in healthy male participants.
Completed
- Conditions
- Multiple sclerosis10007951
- Registration Number
- NL-OMON45777
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
-Healthy male subjects
-18-45 yrs, inclusive
-BMI: 18.0-30.0 kg/m2, inclusive
-Non-smoking or light-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>To evaluate the safety and tolerability of single oral ascending doses of<br /><br>RO7189752 in healthy male participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the PK of RO7189752 in plasma and urine, and if appropriate, its<br /><br>metabolite(s) after single oral doses.<br /><br><br /><br>To assess the PD of RO7189752 after single oral doses.</p><br>