Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-02 @ 4:14 AM
Study NCT ID:
NCT03387657
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2022-04
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:
Primary Objective:
To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.
Secondary Objectives:
* To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ
* To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ
* To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.
Secondary Objectives:
* To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ
* To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ
* To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Detailed Description:
Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1186-2718 | OTHER | UTN | View |