Type 2 Diabetes Mellitus Clinical Trial
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
Verified date | April 2022 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 16 |
Est. completion date | March 2, 2018 |
Est. primary completion date | March 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Investigational Site Number 8400001 | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of PK parameter: AUCtau | Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau) | Period 1, days 2 to 6 | |
Primary | Assessment of PK parameter: AUCtau | Sotagliflozin with HCTZ: AUCtau | Period 2, days 6 to 10 | |
Secondary | Assessment of PK parameter: AUCtau | HCTZ without sotagliflozin: AUCtau | Period 2, days 4 to 5 | |
Secondary | Assessment of PK parameter: AUCtau | HCTZ with sotagliflozin: AUCtau | Period 2, days 9 to 10 | |
Secondary | Assessment of PK parameter: AUCtau | Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau | Period 1, days 2 to 6 | |
Secondary | Assessment of PK parameter: AUCtau | Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau | Period 2, days 6 to 10 | |
Secondary | Assessment of PK parameter: Cmax | HCTZ without sotagliflozin: Maximum plasma concentration (Cmax) | Period 2, days 4 to 5 | |
Secondary | Assessment of PK parameter: Cmax | HCTZ with sotagliflozin: Cmax | Period 2, days 9 to 10 | |
Secondary | Assessment of PK parameter: Cmax | Sotagliflozin-3-O-glucuronide without HCTZ: Cmax | Period 1, days 2 to 6 | |
Secondary | Assessment of PK parameter: Cmax | Sotagliflozin-3-O-glucuronide with HCTZ: Cmax | Period 2, days 6 to 10 | |
Secondary | Assessment of PK parameter: tmax | HCTZ without sotagliflozin: Time to reach Cmax (tmax) | Period 2, days 4 to 5 | |
Secondary | Assessment of PK parameter: tmax | HCTZ with sotagliflozin: tmax | Period 2, days 9 to 10 | |
Secondary | Assessment of PK parameter: tmax | Sotagliflozin-3-O-glucuronide without HCTZ: tmax | Period 1, days 2 to 6 | |
Secondary | Assessment of PK parameter: tmax | Sotagliflozin-3-O-glucuronide with HCTZ: tmax | Period 2, days 6 to 10 | |
Secondary | Assessment of PK parameter: Cmax | Sotagliflozin without HCTZ: Cmax | Period 1, days 2 to 6 | |
Secondary | Assessment of PK parameter: Cmax | Sotagliflozin with HCTZ: Cmax | Period 2, days 6 to 10 | |
Secondary | Assessment of PK parameter: tmax | Sotagliflozin without HCTZ: tmax | Period 1, days 2 to 6 | |
Secondary | Assessment of PK parameter: tmax | Sotagliflozin with HCTZ: tmax | Period 2, days 6 to 10 |
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