NCT03387657

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Hydrochlorothiazide	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2018-01-03
• Primary completion: 2018-03-02
• Completion: 2018-03-02
• First posted: 2018-01-02
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study