Overview

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.