A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects

Sponsor
Sanofi
Study ID
NCT03174548
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Primary Objective: To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects. Secondary Objectives: * To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects. * To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions * To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.

Key Dates

Start date
Jun 12, 2017
Status verified
Apr 2022
Primary completion
Sep 15, 2017
Completion
Sep 15, 2017

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Fed Tablet period (Test, T)
    Sotagliflozin oral in fed conditions
  • Experimental: Fasted Tablet period (Reference, R)
    Sotagliflozin oral in fasting conditions
  • Experimental: Oral Solution period (S)
    Sotagliflozin oral solution in fasting conditions

Primary Outcome Measure

Maximum plasma drug concentration (Cmax) of sotagliflozin [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]

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