Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02924337

Enrollment

Registered

2016-10-05

Start date

2016-09-30

Completion date

2016-12-31

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Qt Interval, Variation in

Keywords

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

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

Interventions

DRUGPlacebo

DRUGImeglimin

DRUGMoxifloxacin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in QTcF (deltaQTcF)	Up to 24 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026