Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses of ODM-108: a single centre study in healthy male volunteers.
Completed
- Conditions
- europathische pijn.Nerve damage pain.
- Registration Number
- NL-OMON42514
- Lead Sponsor
- Orion Corporation Orion Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 206
Inclusion Criteria
Healthy male volunteers
18 - 55 years, inclusive
BMI 18 - 30 kilograms/meter2
Weight 55 - 95 kilograms, inclusive
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>The primary objective of Part I is to evaluate the safety and tolerability of<br /><br>single escalating doses of ODM-108 compared to placebo.<br /><br>The primary objective of Part II is to evaluate the safety and tolerability of<br /><br>repeated, escalating doses of ODM-108 compared to placebo.<br /><br>The primary objective of optional Part III is to evaluate the effect of ODM-108<br /><br>on CYP3A4 activity.</p><br>
- Secondary Outcome Measures
Name Time Method