Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Sotagliflozin (SAR439954); Drug: Mefenamic acid

• Registration Number: NCT03070678
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the effect of multiple dose mefenamic acid 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 400 mg sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.

* To assess the safety and tolerability of sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.

Detailed Description

The expected duration of the study is approximately 59 days per subject, including 2-28 days of screening, treatment period 1 of 7 days, treatment period 2 of 8 days, at least 7 days of wash-out period, and an end of study visit, which is between 14-21 days after the last dose of sotagliflozin.

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Study Start: 2017-03-14
• Primary Completion: 2017-04-18
• Study Completion: 2017-04-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR439954 with or without mefenamic acid	Sotagliflozin (SAR439954)	Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2
SAR439954 with or without mefenamic acid	Mefenamic acid	Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	Up to 144 hours after each SAR439954 intake
Area under the concentration-time curve from 0 to the last quantifiable concentration (AUClast)	Up to 144 hours after each SAR439954 intake
Area under the concentration-time curve from 0 to infinity (AUC0 ∞)	Up to 144 hours after each SAR439954 intake

Secondary Outcome Measures

Name	Time	Method
Total 24-hour UGE (urinary glucose excretion) after each dose with sotagliflozin	Up to 24 hours after each SAR439954 intake

Trial Locations

Locations (1)

Investigational site 250001; 🇫🇷 Gières, France