Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
Phase 1
Completed
- Conditions
- Qt Interval, Variation in
- Interventions
- Registration Number
- NCT02924337
- Lead Sponsor
- Poxel SA
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Tablet, oral, single dose Moxifloxacin Moxifloxacin Tablet, oral, single dose (400 mg) Imeglimin therapeutic dose Imeglimin Tablet, oral, single dose Imeglimin supratherapeutic dose Imeglimin Tablet, oral, single dose
- Primary Outcome Measures
Name Time Method Change from baseline in QTcF (deltaQTcF) Up to 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hammersmith Medicines Research (HMR)
🇬🇧London, United Kingdom