A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

Sponsor
Sanofi
Study ID
NCT03414723
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus
  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: tablets Route of administration: oral
  • Ramipril — DRUG
    Pharmaceutical form: tablets Route of administration: oral

Study Details

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.

Key Dates

Start date
Jan 15, 2018
Status verified
Apr 2022
Primary completion
Mar 10, 2018
Completion
Mar 10, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: SAR439954 with or without 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 Measure

Assessment of PK parameter: AUCtau [ Time Frame: On Day 10 (Period 2) ]

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