Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02647918
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2015-12-30
Brief Title:
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
Sponsor:
Lexicon Pharmaceuticals
Organization:
Lexicon Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Open-label Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function
Status:
COMPLETED
Status Verified Date:
2019-02
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:
The purpose of this study is to evaluate the effect of mild moderate or severe renal impairment or end-stage renal disease ESRD requiring hemodialysis HD on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy demographically-matched subjects with normal renal function
Detailed Description:
None
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 |
|---|---|---|---|
| LX4211121 | OTHER | Lexicon Pharmaceuticals Inc | None |