Trials / Completed
CompletedNCT01822041
14C-ARN-509 Microtracer Label AME and Absolute BA Study
14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion Study in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Aragon Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).
Detailed description
Two cohorts of 6 healthy volunteers will be enrolled for the AME and absolute BA parts, respectively. The dose for both cohorts is 240 mg. The expected exposure of the dose is 7-fold lower than the steady state reached in patients with castration-resistant prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARN-509 | Single oral dose of 240 mg ARN-509 |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2013-04-02
- Last updated
- 2013-09-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01822041. Inclusion in this directory is not an endorsement.