A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects

Sanofi

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Sotagliflozin (SAR439954)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03174548

U1111-1189-5094 (Other Identifier)

PKM15047

2016-004650-15 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Fed Tablet period (Test, T)

Experimental group

Description:

Sotagliflozin oral in fed conditions

Treatment:

Drug: Sotagliflozin (SAR439954)

Drug: Sotagliflozin (SAR439954)

Fasted Tablet period (Reference, R)

Experimental group

Description:

Sotagliflozin oral in fasting conditions

Treatment:

Drug: Sotagliflozin (SAR439954)

Drug: Sotagliflozin (SAR439954)

Oral Solution period (S)

Experimental group

Description:

Sotagliflozin oral solution in fasting conditions

Treatment:

Drug: Sotagliflozin (SAR439954)

Drug: Sotagliflozin (SAR439954)