Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects
Study Details
Study Description
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:
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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.
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To assess the safety and tolerability of sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SAR439954 with or without 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 |
Drug: Sotagliflozin (SAR439954)
Pharmaceutical form: tablet
Route of administration: oral
Drug: Mefenamic acid
Pharmaceutical form: capsule
Route of administration: oral
|
Outcome Measures
Primary Outcome Measures
- 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
- Total 24-hour UGE (urinary glucose excretion) after each dose with sotagliflozin [Up to 24 hours after each SAR439954 intake]
Eligibility Criteria
Criteria
Inclusion criteria :
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Healthy male or female subjects, between 18 and 55 years of age, inclusive.
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Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female.
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Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
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Normal vital signs, ECG, and laboratory parameters, aPTT (activated partial thromboplastin time) should not exceed normal control more than 10 seconds.
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Female subject must use a double contraception method including a highly effective method of birth control except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
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Having given written informed consent prior to undertaking any study-related procedure.
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Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
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Not under any administrative or legal supervision.
Exclusion criteria:
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Any history or presence of clinically relevant disease at screening, which could interfere with the objectives of the study or the safety of the subject's participation.
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Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
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Blood donation, any volume, within 2 months before inclusion.
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Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
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History or presence of drug or alcohol abuse.
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Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
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Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
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If female, pregnancy (defined as positive β-HCG (human chorionic gonadotropin) blood test if applicable), breast-feeding.
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Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to inclusion; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to inclusion; or topical controlled delivery contraceptives (patch) for 3 months prior to inclusion.
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Any subject in the exclusion period of a previous study according to applicable regulations.
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Any subject who cannot be contacted in case of emergency.
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Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational site 250001 | Gières | France |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INT14937
- U1111-1186-2702