A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

NCT ID: NCT02940379

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2016-12-31

Brief Summary

Primary Objective:

To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam.

Secondary Objective:

To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.

Detailed Description

The total study duration per subject is up to 58 days.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days

Group Type: EXPERIMENTAL

sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

midazolam

Intervention Type: DRUG

Pharmaceutical form: HCl syrup

Route of administration: oral

metoprolol

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Cohort 2

Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days

Group Type: EXPERIMENTAL

sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

midazolam

Intervention Type: DRUG

Pharmaceutical form: HCl syrup

Route of administration: oral

metoprolol

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

midazolam

Pharmaceutical form: HCl syrup

Route of administration: oral

Intervention Type: DRUG

metoprolol

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female healthy 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/m^2, inclusive.
• Normal vital signs, electrocardiogram (ECG), and laboratory parameters
• Female subjects must use a double contraception method during the study, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of one of the following contraceptive options: (1) condom; (2) diaphragm or cervical/vault cap; (3) spermicide in addition to the use of one of the following: a) Intrauterine device (IUD); b) Vasectomized partner; c) Sexual abstinence. Hormonal contraception is NOT acceptable in this study.

Exclusion Criteria

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.

Frequent headaches and/or migraine, recurrent nausea and/or vomiting.

• Blood donation, any volume, within 2 months before inclusion.
• Symptomatic postural hypotension.
• Presence or history of drug hypersensitivity, allergic disease or asthma diagnosed and treated by a physician.
• History or presence of drug or alcohol abuse.
• If female, pregnancy or breast-feeding.
• 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; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to the first dose of Period 1; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1; or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1.
• Any contra-indications to metoprolol, according to the applicable labeling.
• Any contra-indications to midazolam, according to the applicable labeling.
• Any consumption of citrus (grapefruit, orange, etc.) or their juices within 5 days before inclusion.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840001

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

U1111-1184-8677

Identifier Type: OTHER

Identifier Source: secondary_id

INT14972

Identifier Type: -

Identifier Source: org_study_id