A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387657
• Other study ID #: INT14905
• Secondary ID: U1111-1186-2718
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2018
• Est. completion date: March 2, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sotagliflozin (SAR439954)
Pharmaceutical form: Tablet Route of administration: Oral
• Hydrochlorothiazide
Pharmaceutical form: Tablet Route of administration: Oral

Locations

Country	Name	City	State
United States	Investigational Site Number 8400001	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

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