Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects

Sponsor
Sanofi
Study ID
NCT03070678
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Mefenamic acid — DRUG
    Pharmaceutical form: capsule Route of administration: oral

Study Details

Primary Objective: To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects. Secondary Objectives: * To assess total 24 hour urinary glucose excretion (UGE) after 400 mg sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects. * To assess the safety and tolerability of sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.

Key Dates

Start date
Mar 14, 2017
Status verified
Apr 2022
Primary completion
Apr 18, 2017
Completion
Apr 18, 2017

Study Design

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

Arms

  • Experimental: SAR439954 with or without mefenamic acid
    Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2

Primary Outcome Measure

Maximum plasma concentration (Cmax) [ Time Frame: Up to 144 hours after each SAR439954 intake ]

Related Studies