Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03931590
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2019-04-25
Brief Title:
A Human AME Study for Omaveloxolone
Sponsor:
Reata a wholly owned subsidiary of Biogen
Organization:
Biogen
Study Overview
Official Title:
Phase 1 Study to Investigate the Absorption Metabolism and Excretion of 14C Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-02
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 study will assess the pharmacokinetics PK mass balance metabolite profiles and rates and routes of elimination of 14C omaveloxolone and derived metabolites following administration as a single 150 mg containing approximately 90 µCi dose to healthy male subjects
Detailed Description:
Study Sponsor originally Reata Pharmaceuticals Inc is now Reata Pharmaceuticals Inc a wholly owned subsidiary of Biogen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None