Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: 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 interval

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Poxel SA
• Treatments: 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.