NCT03063580

Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin

A Phase 1, Single-center, Open-label, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Rifampicin on the Pharmacokinetics and Pharmacodynamics of Single Dose Sotagliflozin in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects. Secondary Objectives: * To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects. * To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.

Detailed description

The expected duration of the study is approximately 53 days total, including 2-28 days of screening, treatment periods of 6 days and 11 days, 1 day of end of study visit, and at least 7 days of follow-up visit.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablets Route of administration: oral
DRUG	Rifampicin	Pharmaceutical form: capsules Route of administration: oral

Timeline

• Start date: 2017-02-27
• Primary completion: 2017-05-12
• Completion: 2017-05-12
• First posted: 2017-02-24
• Last updated: 2022-04-25

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study