Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects (NCT02924337) | Clinical Trial Compass
CompletedPhase 1
Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
United Kingdom55 participantsStarted 2016-09
Plain-language summary
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
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.