A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

Phase 1

Completed

• Conditions: Healthy Subjects; Diabetes Mellitus
• Interventions: Drug: Sotagliflozin (SAR439954); Drug: Ramipril

• Registration Number: NCT03414723
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK) parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in healthy male and female subjects.

Secondary Objectives:

* To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its active metabolite (ramiprilat).

* To assess the safety and tolerability of multiple-dose sotagliflozin with and without multiple-dose of ramipril.

Detailed Description

The expected duration of subject participation, including Screening of up to 29 days, Treatment Periods of 6 days and 11 days each with a Washout period of minimum of 7 days in between periods, Follow-up period of 6 days, and end-of-study-period of 10-14 days after last sotagliflozin dose, is approximately 66 days.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Primary Completion: 2018-03-10
• Study Completion: 2018-03-10
• 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
SAR439954 with or without ramipril	Sotagliflozin (SAR439954)	* On Period 1, following an overnight fast, subjects will receive once daily single morning oral intake of sotagliflozin from Day 1 to Day 5 followed by the first meal that has to be started within 10 min after dosing. * On Day 1 of the Period 2, study subjects will begin a 10-day ramipril regimen following an overnight fast. From Day 6 to Day 10, subjects will receive once daily single morning oral intake of ramipril concomitantly to the sotagliflozin dosing.
SAR439954 with or without ramipril	Ramipril	* On Period 1, following an overnight fast, subjects will receive once daily single morning oral intake of sotagliflozin from Day 1 to Day 5 followed by the first meal that has to be started within 10 min after dosing. * On Day 1 of the Period 2, study subjects will begin a 10-day ramipril regimen following an overnight fast. From Day 6 to Day 10, subjects will receive once daily single morning oral intake of ramipril concomitantly to the sotagliflozin dosing.

Primary Outcome Measures

Name	Time	Method
Assessment of PK parameter: AUCtau	On Day 5 (Period 1)	Sotagliflozin without ramipril: AUCtau

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter: Cmax	On Day 5 (Period 1)	Sotagliflozin without ramipril: Cmax
Assessment of PK parameter: tmax	On Day 5 (Period 1)	Sotagliflozin without ramipril: tmax
Adverse events	Up to Day 37	Number of adverse events

Trial Locations

Locations (1)

Investigational Site Number 2760001; 🇩🇪 Berlin, Germany