NCT02924337
Completed
Phase 1
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
ConditionsQt Interval, Variation in
Overview
- Phase
- Phase 1
- Intervention
- Imeglimin
- Conditions
- Qt Interval, Variation in
- Sponsor
- Poxel SA
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Change from baseline in QTcF (deltaQTcF)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
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
Arms & Interventions
Imeglimin therapeutic dose
Tablet, oral, single dose
Intervention: Imeglimin
Imeglimin supratherapeutic dose
Tablet, oral, single dose
Intervention: Imeglimin
Placebo
Tablet, oral, single dose
Intervention: Placebo
Moxifloxacin
Tablet, oral, single dose (400 mg)
Intervention: Moxifloxacin
Outcomes
Primary Outcomes
Change from baseline in QTcF (deltaQTcF)
Time Frame: Up to 24 hours
Study Sites (1)
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