A phase I, open-label study to investigate the absorption, metabolism, excretion, and mass balance of [14C]QLT091001 following single oral dose in healthy male subjects
Completed
- Conditions
- inherited retinal diseases10042261
- Registration Number
- NL-OMON35776
- Lead Sponsor
- QLT Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Healthy male
Exclusion Criteria
Clinical significant abnormalities at medical research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize the biotransformation pathways, the routes and rates of<br /><br>excretion, and total recovery of the 14C-labeled research medication and its<br /><br>radiolabeled metabolites.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To characterize the pharmacokinetics (PK) of the research medication and its<br /><br>major metabolites.<br /><br>To document the safety and tolerability.</p><br>