Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| napabucasin | Drug | Single 240 mg dose containing 100 μCi of 14C-napabucasin will be administered with 240 mL of water following an overnight fast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics for napabucasin and metabolites by assessing plasma concentration | 1 week | |
| Pharmacokinetics for napabucasin and metabolites by assessing urinary concentration | Up to 12 days | |
| Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration | Up to 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Adverse Events | 4 weeks |
Not provided
Inclusion criteria
1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
2. Subject is male. 3. Subject is between the ages of 18 and 45 years, inclusive at screening. 4. Subject has a body mass index between 18 and 34 kg/m^2 (weight/[height]^2) inclusive at screening.
5. Subject has normal (or abnormal and clinically insignificant according to the Investigator) laboratory values at screening. 6. Subject is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, or clinical laboratory evaluations at Screening or Check-in Day -1 as assessed by the Investigator (or designee). Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
7. Subject has not consumed and agrees to abstain from taking any dietary supplements, herbal products, and non-prescription drugs (except as authorized by the Investigator and Medical Monitor) for 14 days prior to clinical research unit (CRU) admission through follow-up call.
8. Subject has not consumed and agrees to abstain from taking any prescription drugs (except as authorized by the Investigator and Medical Monitor) during the 14 days prior to CRU admission through follow-up call.
9. Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through clinic discharge. 10. Subject has not consumed char-broiled meats, cruciferous vegetables, and grapefruit-, apple-, or Seville orange-containing products within the 3 days prior to CRU admission and agrees not to consume Seville oranges, grapefruit and grapefruit juice through clinic discharge.
11. Subject has not used tobacco- and nicotine-containing products within 2 months prior to the CRU admission and agrees to abstain from using tobacco- and nicotine-containing products through clinic discharge.
12. Subject agrees to abstain from consuming caffeine- or xanthine-containing products from 3 days prior to CRU admission through clinic discharge.
13. History of a minimum of 1 bowel movement per day Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
Not provided
| ID | Term |
|---|---|
| C000621033 | napabucasin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided