NCT03414723

A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

An Open Label, 2-treatment, 2-period, Single Sequence Study to Evaluate Pharmacokinetic Drug-drug Interaction Between Ramipril and Sotagliflozin at Steady State in Healthy 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 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.

Conditions

• Diabetes Mellitus
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablets Route of administration: oral
DRUG	Ramipril	Pharmaceutical form: tablets Route of administration: oral

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-03-10
• Completion: 2018-03-10
• First posted: 2018-01-30
• Last updated: 2022-04-25

Locations

1 site across 1 country: Germany