An open label, single dose, single period study to assess the mass balance recovery, metabolite profile and metabolite identification of [14C] APD421 administered via the intravenous route to healthy male subjects
Completed
- Conditions
- misselijkheid en brakennauseavomiting
- Registration Number
- NL-OMON42878
- Lead Sponsor
- Acacia Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male subjects
18-65 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 3 months before the start of this study or being a blood donor within 3 months from the start of the study. In case of donating more than 100 ml of blood in the 3 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To assess the mass balance recovery after a single IV dose of [14C]-APD421<br /><br>- To identify the chemical structure of each metabolite accounting for * 10% of<br /><br>parent compound exposure<br /><br>- To determine the routes and rates of elimination of [14C]-APD421</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To further explore the IV PK of [14C]-APD421<br /><br>- To evaluate the extent of distribution of total radioactivity into blood cells<br /><br>- To provide additional safety and tolerability information for APD421</p><br>