Status:
COMPLETED
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 tol...
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 fo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03387657
Start Date
January 3 2018
End Date
March 2 2018
Last Update
April 25 2022
Active Locations (1)
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1
Investigational Site Number 8400001
Dallas, Texas, United States, 75247