Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects

The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval

Inclusion Criteria:

• healthy volunteers
• BMI between 18.5 and 29.9 kg/m2
• weighing between 55 and 95 kg
• willing to use reliable contraception
• able to give fully informed written consent.

Exclusion Criteria:

• Pregnant or lactating woman, or sexually active woman of child-bearing potential not using highly effective contraception
• clinically relevant abnormal medical history, surgery or concurrent medical condition; acute or chronic illness
• clinically significant QT/QTc interval prolongation at Baseline
• history of drug-induced or risk factors for Torsade de Pointes
• any contraindication to moxifloxacin
• severe adverse reaction to any drug or sensitivity to the trial medication or its components
• significant food allergy; use of vitamins, herbal medicines, prescription or over-the-counter medication (with the exception of paracetamol [acetaminophen] and oral contraceptives for women) within 20 days or 6 half-lives before first dose of trial medication
• participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
• drug or alcohol abuse; smoking of more than 5 cigarettes, 1 cigars or 1 pipes daily
• regular consumption of more than 5 cups of caffeinated drinks per day
• positive test for hepatitis A, B & C, HIV
• objection by a General Practitioner.