Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

Poxel

Status and phase: Completed; Phase 1

Conditions: Qt Interval, Variation in

Treatments: Drug: Placebo; Drug: Imeglimin; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02924337

2016-001821-14 (EudraCT Number)

PXL008-016

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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55 participants in 4 patient groups, including a placebo group

Imeglimin therapeutic dose

Experimental group

Description:

Tablet, oral, single dose

Treatment:

Drug: Imeglimin

Imeglimin supratherapeutic dose

Experimental group

Description:

Tablet, oral, single dose

Treatment:

Drug: Imeglimin

Placebo

Placebo Comparator group

Description:

Tablet, oral, single dose

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

Tablet, oral, single dose (400 mg)

Treatment:

Drug: Moxifloxacin