NCT03802487

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

A Phase 1, Single-Center, Open-Label, Two-Period, One-Sequence, Single Dose Study to Determine the Absolute Bioavailability of Sotagliflozin in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Study duration per participant is up to 54 days including a screening period of up to 28 days, period 1 of 8 days, period 2 of 8 days, a washout period of at least 10 days, and a follow up period of 12-16 days. The oral drug Sotagliflozin is metabolized by the liver and released in the bile juice into the intestine. Ingestion of charcoal a few hours after the drug administration circumvents the re-uptake of the drug from the intestine back into the blood circulation; instead, Sotagliflozin is eliminated with the feces. By comparison of Sotagliflozin drug administration with and without charcoal, the extent of this so-called enterohepatic circulation can be assessed.

Conditions

• Type 2 Diabetes Mellitus
• Healthy Subjects

Interventions

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

Timeline

• Start date: 2019-01-14
• Primary completion: 2019-03-28
• Completion: 2019-03-28
• First posted: 2019-01-14
• Last updated: 2022-04-25

Locations

1 site across 1 country: United Kingdom