NCT02940379

A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

A Two-cohort, Open-label, Fixed-sequence, Two-period, Two-treatment Pharmacokinetic Interaction Study of Repeated Oral Doses of Sotagliflozin on a Single Dose Cocktail of Metoprolol and Midazolam Used as Probe Substrates for CYP2D6 and CYP3A Activities, Respectively, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam. Secondary Objective: To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.

Detailed description

The total study duration per subject is up to 58 days.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	sotagliflozin (SAR439954)	Pharmaceutical form: tablet Route of administration: oral
DRUG	midazolam	Pharmaceutical form: HCl syrup Route of administration: oral
DRUG	metoprolol	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-10-20
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States