A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

NCT03387657 | Completed Phase 1 FDA Drug

• 2 other identifiers: INT14905U1111-1186-2718
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Assessment of PK parameter: AUCtau

  Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)

  Period 1, days 2 to 6

• Assessment of PK parameter: AUCtau

  Sotagliflozin with HCTZ: AUCtau

  Period 2, days 6 to 10

Secondary Outcomes (16)

• Assessment of PK parameter: AUCtau

  Period 2, days 4 to 5

• Assessment of PK parameter: AUCtau

  Period 2, days 9 to 10

• Assessment of PK parameter: AUCtau

  Period 1, days 2 to 6

• Assessment of PK parameter: AUCtau

  Period 2, days 6 to 10

• Assessment of PK parameter: Cmax

  Period 2, days 4 to 5

Study Arms (1)

Sotagliflozin + Hydrochlorothiazide (HCTZ)

EXPERIMENTAL

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); Drug: Hydrochlorothiazide

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Sotagliflozin + Hydrochlorothiazide (HCTZ)

Hydrochlorothiazide DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Sotagliflozin + Hydrochlorothiazide (HCTZ)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 8400001

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 2, 2018
• Study Start: January 3, 2018
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)