Clinical trial NCT03387657: A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of PK parameter: AUCtau
timeFrame: Period 1, days 2 to 6
measure: Assessment of PK parameter: AUCtau
timeFrame: Period 2, days 6 to 10
Secondary outcomes:
measure: Assessment of PK parameter: AUCtau
timeFrame: Period 2, days 4 to 5
measure: Assessment of PK parameter: AUCtau
timeFrame: Period 2, days 9 to 10
measure: Assessment of PK parameter: AUCtau
timeFrame: Period 1, days 2 to 6
measure: Assessment of PK parameter: AUCtau
timeFrame: Period 2, days 6 to 10
measure: Assessment of PK parameter: Cmax
timeFrame: Period 2, days 4 to 5
measure: Assessment of PK parameter: Cmax
timeFrame: Period 2, days 9 to 10
measure: Assessment of PK parameter: Cmax
timeFrame: Period 1, days 2 to 6
measure: Assessment of PK parameter: Cmax
timeFrame: Period 2, days 6 to 10
measure: Assessment of PK parameter: tmax
timeFrame: Period 2, days 4 to 5
measure: Assessment of PK parameter: tmax
timeFrame: Period 2, days 9 to 10
measure: Assessment of PK parameter: tmax
timeFrame: Period 1, days 2 to 6
measure: Assessment of PK parameter: tmax
timeFrame: Period 2, days 6 to 10
measure: Assessment of PK parameter: Cmax
timeFrame: Period 1, days 2 to 6
measure: Assessment of PK parameter: Cmax
timeFrame: Period 2, days 6 to 10
measure: Assessment of PK parameter: tmax
timeFrame: Period 1, days 2 to 6
measure: Assessment of PK parameter: tmax
timeFrame: Period 2, days 6 to 10
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Investigational Site Number 8400001
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: