Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Sponsor
Sanofi
Study ID
NCT03909451
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Placebo — DRUG
    Pharmaceutical form: tablet Route of administration: oral

Study Details

Primary Objective: To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects. Secondary Objectives: * To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects. * To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.

Key Dates

Start date
Apr 28, 2019
Status verified
Apr 2022
Primary completion
Aug 19, 2019
Completion
Aug 19, 2019

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose 1
    Sotagliflozin dose 1, once daily for 8 days
  • Experimental: Dose 2
    Sotagliflozin dose 2, once daily for 8 days
  • Placebo Comparator: Placebo
    Placebo, once daily for 8 days

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: Up to 41 days ]

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