Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Qt Interval, Variation in

Intervention / Treatment
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* Drug: Placebo
* Drug: Imeglimin
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imeglimin therapeutic dose<br>Tablet, oral, single dose | Drug: Imeglimin<br> <br> |
| Experimental: Imeglimin supratherapeutic dose<br>Tablet, oral, single dose | Drug: Imeglimin<br> <br> |
| Placebo Comparator: Placebo<br>Tablet, oral, single dose | Drug: Placebo<br> <br> |
| Active Comparator: Moxifloxacin<br>Tablet, oral, single dose (400 mg) | Drug: Moxifloxacin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QTcF (deltaQTcF) |  | Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QT/QTC interval, Hypoglycemic Agents, Imeglimin, Healthy Volunteers