An Open Label Study to Determine ADME of [14C] labeled SLV334 and its Metabolites after Single Intravenous Dose Infusion.
Completed
- Conditions
- Traumatische hersenbeschadigingBrain injuryTherapy
- Registration Number
- NL-OMON34670
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
- Healthy male
- 18-55 years of age, inclusive
- BMI 18.0 - 28.0 kg/m2 (weight between 50 and 100 kg inclusive)
- non-smoker
Exclusion Criteria
Suffering from: hepatitis B, 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>Radiodynamics<br /><br>Pharmacokinetics<br /><br>Safety</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>