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

NCT03802487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-04-25

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2019-03-28
Completion
2019-03-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802487 on ClinicalTrials.gov