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A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03387657
Recruitment Status : Recruiting
First Posted : January 1, 2018
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary Objective:

To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.

Secondary Objectives:

  • To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ
  • To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ
  • To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: Hydrochlorothiazide Phase 1

Detailed Description:
Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sotagliflozin + Hydrochlorothiazide (HCTZ)
Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: Tablet

Route of administration: Oral

Drug: Hydrochlorothiazide

Pharmaceutical form: Tablet

Route of administration: Oral



Outcome Measures

Primary Outcome Measures :
  1. Assessment of PK parameter: AUCtau [ Time Frame: Period 1, days 2 to 6 ]
    Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)

  2. Assessment of PK parameter: AUCtau [ Time Frame: Period 2, days 6 to 10 ]
    Sotagliflozin with HCTZ: AUCtau


Secondary Outcome Measures :
  1. Assessment of PK parameter: AUCtau [ Time Frame: Period 2, days 4 to 5 ]
    HCTZ without sotagliflozin: AUCtau

  2. Assessment of PK parameter: AUCtau [ Time Frame: Period 2, days 9 to 10 ]
    HCTZ with sotagliflozin: AUCtau

  3. Assessment of PK parameter: AUCtau [ Time Frame: Period 1, days 2 to 6 ]
    Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau

  4. Assessment of PK parameter: AUCtau [ Time Frame: Period 2, days 6 to 10 ]
    Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau

  5. Assessment of PK parameter: Cmax [ Time Frame: Period 2, days 4 to 5 ]
    HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)

  6. Assessment of PK parameter: Cmax [ Time Frame: Period 2, days 9 to 10 ]
    HCTZ with sotagliflozin: Cmax

  7. Assessment of PK parameter: Cmax [ Time Frame: Period 1, days 2 to 6 ]
    Sotagliflozin-3-O-glucuronide without HCTZ: Cmax

  8. Assessment of PK parameter: Cmax [ Time Frame: Period 2, days 6 to 10 ]
    Sotagliflozin-3-O-glucuronide with HCTZ: Cmax

  9. Assessment of PK parameter: tmax [ Time Frame: Period 2, days 4 to 5 ]
    HCTZ without sotagliflozin: Time to reach Cmax (tmax)

  10. Assessment of PK parameter: tmax [ Time Frame: Period 2, days 9 to 10 ]
    HCTZ with sotagliflozin: tmax

  11. Assessment of PK parameter: tmax [ Time Frame: Period 1, days 2 to 6 ]
    Sotagliflozin-3-O-glucuronide without HCTZ: tmax

  12. Assessment of PK parameter: tmax [ Time Frame: Period 2, days 6 to 10 ]
    Sotagliflozin-3-O-glucuronide with HCTZ: tmax

  13. Assessment of PK parameter: Cmax [ Time Frame: Period 1, days 2 to 6 ]
    Sotagliflozin without HCTZ: Cmax

  14. Assessment of PK parameter: Cmax [ Time Frame: Period 2, days 6 to 10 ]
    Sotagliflozin with HCTZ: Cmax

  15. Assessment of PK parameter: tmax [ Time Frame: Period 1, days 2 to 6 ]
    Sotagliflozin without HCTZ: tmax

  16. Assessment of PK parameter: tmax [ Time Frame: Period 2, days 6 to 10 ]
    Sotagliflozin with HCTZ: tmax


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion criteria :

  • 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, body mass index between 18.0 and 30.0 kg/m2, inclusive.
  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
  • Normal vital signs, electrocardiogram, and laboratory parameters.
  • 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. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone level >30 IU. Hormonal contraception is NOT acceptable in this study.
  • Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.
  • Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.
  • Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.

Exclusion criteria:

  • 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, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
  • Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
  • Positive result on urine drug screen or alcohol test.
  • Any contra-indications to hydrochlorothiazide, according to the applicable labeling.
  • Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

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): NCT03387657


Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
United States, Texas
Investigational Site Number 8400001 Recruiting
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03387657     History of Changes
Other Study ID Numbers: INT14905
U1111-1186-2718 ( Other Identifier: UTN )
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action