Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects

Sponsor
Sanofi
Study ID
NCT03802487
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral
  • 14C-microtracer — DRUG
    Pharmaceutical form: Solution for injection Route of administration: Intravenous
  • Charcoal — DRUG
    Pharmaceutical form: Granules for suspension Route of administration: Oral

Study Details

Primary Objective: To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal administration Secondary Objectives: * To assess the PK of sotagliflozin and its main metabolite sotagliflozin-3-O-glucuronide (M19) after a single oral dose of sotagliflozin and an IV microdose of a 14C-sotagliflozin tracer without charcoal administration * To assess the safety and tolerability of single doses of sotagliflozin when administered with and without charcoal

Key Dates

Start date
Jan 14, 2019
Status verified
Apr 2022
Primary completion
Mar 28, 2019
Completion
Mar 28, 2019

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sotagliflozin
    One treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer plus charcoal. The other treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer without charcoal.

Primary Outcome Measure

Pharmacokinetic (PK) parameter: Absolute Bioavailability (F) [ Time Frame: Baseline to Day 8 of period 1 (without charcoal) ]

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