Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

NCT02924337 | Completed Phase 1

• 2 other identifiers: PXL008-0162016-001821-14
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Qt Interval, Variation in

Keywords

QT/QTC interval; Hypoglycemic Agents; Imeglimin; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change from baseline in QTcF (deltaQTcF)

  Up to 24 hours

Study Arms (4)

Imeglimin therapeutic dose

EXPERIMENTAL

Tablet, oral, single dose

Drug: Imeglimin

Imeglimin supratherapeutic dose

EXPERIMENTAL

Tablet, oral, single dose

Drug: Imeglimin

Placebo

PLACEBO COMPARATOR

Tablet, oral, single dose

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Tablet, oral, single dose (400 mg)

Drug: Moxifloxacin

Interventions

Placebo DRUG

Placebo

Imeglimin DRUG

Imeglimin supratherapeutic dose; Imeglimin therapeutic dose

Moxifloxacin DRUG

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poxel SA: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Location

Related Publications (1)

• Dubourg J, Perrimond-Dauchy S, Felices M, Bolze S, Voiriot P, Fouqueray P. Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus. Eur J Clin Pharmacol. 2020 Oct;76(10):1393-1400. doi: 10.1007/s00228-020-02929-6. Epub 2020 Jun 18.

  PMID: 32556539 DERIVED

MeSH Terms

Interventions

imeglimin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Julie Dubourg, MD

  Poxel SA

  STUDY DIRECTOR

• Pascale Fouqueray, MD, PhD

  Poxel SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

GB (1)