Clinical trial NCT03174548: A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
Official title: A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.

Secondary Objectives:

* To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects.
* To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions
* To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.

Detailed description: The study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational Medicinal Product administration in period 3.

Eligibility criteria: Inclusion criteria :

* Healthy male and female subjects, between 18 and 55 years of age, inclusive, at the time of screening.
* 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), vital signs, ECG, and clinical laboratory parameters.

Exclusion criteria:

* Any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
* Blood donation any volume, within 2 months before inclusion.
* Symptomatic postural hypotension.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse.
* Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
* If female, pregnancy, 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Maximum plasma drug concentration (Cmax) of sotagliflozin
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Area under curve (AUC) of sotagliflozin
timeFrame: From 0 to 120 hours after sotagliflozin intake
Secondary outcomes:
measure: Sotagliflozin (tablet and oral solution):Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin (tablet and oral solution): Time to reach maximum plasma concentration (tmax)
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin (tablet and oral solution): Elimination half-life (t1/2z)
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin-O-glucuronide (tablet and oral solution): Cmax
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin-O-glucuronide (tablet and oral solution): tmax
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin-O-glucuronide (tablet and oral solution): t1/2z
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin-O-glucuronide (tablet and oral solution): Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Sotagliflozin-O-glucuronide (tablet and oral solution): AUC
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Relative bioavailability (Frel)
timeFrame: From 0 to 120 hours after sotagliflozin intake
measure: Number (%) of subjects with treatment emergent adverse events
timeFrame: Over 9 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Investigational Site Number 826001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: