Type 2 Diabetes Mellitus
Conditions
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
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.
Interventions
Pharmaceutical form: Tablet Route of administration: Oral
DRUGHydrochlorothiazide
Pharmaceutical form: Tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK parameter: AUCtau | Period 1, days 2 to 6 | Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK parameter: AUCtau | Period 2, days 4 to 5 | HCTZ without sotagliflozin: AUCtau |
| Assessment of PK parameter: Cmax | Period 2, days 4 to 5 | HCTZ without sotagliflozin: Maximum plasma concentration (Cmax) |
| Assessment of PK parameter: tmax | Period 2, days 4 to 5 | HCTZ without sotagliflozin: Time to reach Cmax (tmax) |
Countries
United States
Outcome results
None listed