A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
- Registration Number
- NCT03525405
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Dose napabucasin -
- Primary Outcome Measures
Name Time Method Pharmacokinetics for napabucasin and metabolites by assessing urinary concentration Up to 12 days Pharmacokinetics for napabucasin and metabolites by assessing plasma concentration 1 week Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration Up to 12 days
- Secondary Outcome Measures
Name Time Method Number of Patients with Adverse Events 4 weeks
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States