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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sotagliflozin (SAR439954); Drug: midazolam; Drug: metoprolol

• Registration Number: NCT02940379
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	sotagliflozin (SAR439954)	Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
Cohort 2	midazolam	Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
Cohort 1	sotagliflozin (SAR439954)	Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
Cohort 1	metoprolol	Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
Cohort 1	midazolam	Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
Cohort 2	metoprolol	Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days

Primary Outcome Measures

Name	Time	Method
Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC)	Day 1 to Day 2 of Treatment A Period
Assessment of midazolam PK parameter: AUC	Day 11 to Day 12 of Treatment B Period
Assessment of metoprolol PK parameter: AUC	Day 11 to Day 13 of Treatment B Period

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter: Cmax	Day 11 to Day 13 of Treatment B Period (metoprolol)
Assessment of PK parameter: time to reach Cmax (Tmax)	Day 1 to Day 2 of Treatment A Period (midazolam)
Assessment of PK parameter: Tmax	Day 11 to Day 13 of Treatment B Period (metoprolol)
Assessment of PK parameter: t1/2z	Day 11 to Day 13 of Treatment B Period (metoprolol)
Assessment of PK parameter: maximum plasma concentration (Cmax)	Day 1 to Day 2 of Treatment A Period (midazolam)
Assessment of PK parameter: terminal-half life (t1/2z)	Day 1 to Day 2 of Treatment A Period (midazolam)

Trial Locations

Locations (1)

Investigational Site Number 840001; 🇺🇸 Knoxville, Tennessee, United States