Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin

Sponsor
Sanofi
Study ID
NCT03063580
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: tablets Route of administration: oral
  • Rifampicin — DRUG
    Pharmaceutical form: capsules Route of administration: oral

Study Details

Primary Objective: To evaluate the effects of rifampicin 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 a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects. * To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.

Key Dates

Start date
Feb 27, 2017
Status verified
Apr 2022
Primary completion
May 12, 2017
Completion
May 12, 2017

Study Design

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

Arms

  • Experimental: SAR439954 with or without rifampicin
    Period 1: single oral dose of 400 mg sotagliflozinon Day 1 morning Period 2: once-daily oral doses of 600 mg rifampicin from Days 1 to 10 and a single oral dose of 400 mg sotagliflozin

Primary Outcome Measure

Maximum plasma concentration (Cmax) [ Time Frame: Up to 96 hours post SAR439954 dosing ]

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