NCT03525405CompletedPhase 1
A Phase I, Open Label, Single Dose Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
Sumitomo Pharma America, Inc.1 site in 1 country8 target enrollmentStarted: May 18, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Single Dose
Experimental
Intervention: napabucasin (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration
Time Frame: Up to 12 days
Pharmacokinetics for napabucasin and metabolites by assessing plasma concentration
Time Frame: 1 week
Pharmacokinetics for napabucasin and metabolites by assessing urinary concentration
Time Frame: Up to 12 days
Secondary Outcomes
- Number of Patients with Adverse Events(4 weeks)
Investigators
Study Sites (1)
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