Overview
Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2016-12-01
2016-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 intervalPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Poxel SATreatments:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
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
- positive test for hepatitis A, B & C, HIV
- objection by a General Practitioner.