A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of Radiolabeled [14C] R924548 Following Single Oral Dose Administration in Healthy Male Subjects
Completed
- Conditions
- immune-mediated diseasesrheuma10003816
- Registration Number
- NL-OMON37118
- Lead Sponsor
- Rigel Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Healthy male volunteers
18-55 years of age
BMI 18.0-31.0 kg/m2
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/AIDS.
Participation in another drug study within 3 months before the start of this study.
Blood donation within 3 months from the start of this study or in case you have donated more than 1.5 liters of blood in the 10 months before the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Plasma PK of R507 and R689<br /><br>- Total concentration radioactivity in plasma and whole blood over time<br /><br>- Total amount of radioactivity recovered in urine and feces<br /><br>- Characterized metabolites of R924548 (R548) in plasma, urine, and feces</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability: adverse events, vital signs, ECG-parameters,<br /><br>laboratory parameters, physical examination</p><br>