Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01822041
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2013-02-26
Brief Title:
14C-ARN-509 Microtracer Label AME and Absolute BA Study
Sponsor:
Aragon Pharmaceuticals Inc
Organization:
Aragon Pharmaceuticals Inc
Study Overview
Official Title:
14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption Metabolism and Excretion Study in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-004899-19 | EUDRACT_NUMBER | None | None |