Trials / Completed
CompletedNCT03525405
A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
A Phase I, Open Label, Single Dose Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | napabucasin | Single 240 mg dose containing 100 μCi of 14C-napabucasin will be administered with 240 mL of water following an overnight fast. |
Timeline
- Start date
- 2018-05-18
- Primary completion
- 2018-06-02
- Completion
- 2018-06-02
- First posted
- 2018-05-15
- Last updated
- 2023-11-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03525405. Inclusion in this directory is not an endorsement.