A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sotagliflozin (SAR439954); Drug: Hydrochlorothiazide

• Registration Number: NCT03387657
• Lead Sponsor: Sanofi

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

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 Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Study Start: 2018-01-03
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sotagliflozin + Hydrochlorothiazide (HCTZ)	Sotagliflozin (SAR439954)	Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.
Sotagliflozin + Hydrochlorothiazide (HCTZ)	Hydrochlorothiazide	Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.

Primary Outcome Measures

Name	Time	Method
Assessment of PK parameter: AUCtau	Period 2, days 6 to 10	Sotagliflozin with HCTZ: AUCtau

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter: Cmax	Period 2, days 6 to 10	Sotagliflozin with HCTZ: Cmax
Assessment of PK parameter: AUCtau	Period 2, days 6 to 10	Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau
Assessment of PK parameter: tmax	Period 2, days 6 to 10	Sotagliflozin with HCTZ: tmax

Trial Locations

Locations (1)

Investigational Site Number 8400001; 🇺🇸 Dallas, Texas, United States