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Mefenamic acid

Phase 1

Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Apr 25, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Mefenamic acid · 1 trial · 1 indication

Phase 1 1
NCT03070678Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female SubjectsDiabetes Mellitus
COMPLETED16 Analytics
PHASE1COMPLETED
Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects
Diabetes Mellitus
NCT0307067816
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Study Endpoints

Primary Endpoints

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 Endpoints

Total 24-hour UGE (urinary glucose excretion) after each dose with sotagliflozin
Up to 24 hours after each SAR439954 intake
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
SAR439954 with or without mefenamic acidEXPERIMENTALPeriod 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

Interventions

NameTypeDescription
Sotagliflozin (SAR439954)DRUGPharmaceutical form: tablet Route of administration: oral
Mefenamic acidDRUGPharmaceutical form: capsule Route of administration: oral
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria : * Healthy male or female subjects, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female. * Certified as healthy by a comprehensive clinical assessment (detailed medical history...

Countries:France
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