Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070678
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: Mefenamic acid 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-label, Cross Over, Single-sequence, Two Periods Phase 1 Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Mefenamic Acid, a Known UGT1A9 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of Single-dose Sotagliflozin in Healthy Male and Female Subjects
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : April 18, 2017


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





Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Up to 144 hours after each SAR439954 intake ]
  2. Area under the concentration-time curve from 0 to the last quantifiable concentration (AUClast) [ Time Frame: Up to 144 hours after each SAR439954 intake ]
  3. Area under the concentration-time curve from 0 to infinity (AUC0 ∞) [ Time Frame: Up to 144 hours after each SAR439954 intake ]

Secondary Outcome Measures :
  1. Total 24-hour UGE (urinary glucose excretion) after each dose with sotagliflozin [ Time Frame: Up to 24 hours after each SAR439954 intake ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 and complete physical examination).
  • Normal vital signs, ECG, and laboratory parameters, aPTT (activated partial thromboplastin time) should not exceed normal control more than 10 seconds.
  • 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.
  • Having given written informed consent prior to undertaking any study-related procedure.
  • 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.
  • Not under any administrative or legal supervision.

Exclusion criteria:

  • 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.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
  • Blood donation, any volume, within 2 months before inclusion.
  • 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.
  • History or presence of drug or alcohol abuse.
  • Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
  • Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
  • If female, pregnancy (defined as positive β-HCG (human chorionic gonadotropin) blood test if applicable), breast-feeding.
  • 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.
  • Any subject in the exclusion period of a previous study according to applicable regulations.
  • Any subject who cannot be contacted in case of emergency.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070678


Locations
Layout table for location information
France
Investigational site 250001
Gières, France
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03070678    
Other Study ID Numbers: INT14937
U1111-1186-2702 ( Other Identifier: UTN )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Mefenamic Acid
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors