NCT02924337

CompletedPhase 1

Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

Poxel SA Source

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Other study identifiers

Sponsor study identifier

PXL008-016

Secondary identifiers

2016-001821-14

EUDRACT_NUMBER

2016

NIH

Study Type

interventional

Actual enrollment (reported)

55

Locations

1 country

Sites

1

Timeline

Study Start

September 2016

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2016

Actual (reported)

Study Completion

December 2016

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 55 participants
Study completion date: December 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2016
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 4, 2016
Actual (reported)
First Posted
October 5, 2016
Actual (reported)
Primary Completion
December 2016
Actual (reported)
Study Completion
December 2016
Actual (reported)

Last Updated: February 10, 2017
Status Verified: February 2017
Last Update Submitted: February 9, 2017

Conditions

Qt Interval, Variation in

Keywords

QT/QTC intervalHypoglycemic AgentsImegliminHealthy 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

Interventions

PlaceboDrug

Placebo

ImegliminDrug

Imeglimin supratherapeutic doseImeglimin therapeutic dose

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

healthy volunteers
BMI between 18.5 and 29.9 kg/m2

Sponsors & Collaborators

Poxel SA
Industrylead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

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: 32556539DERIVED

MeSH Terms

Interventions

imegliminMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Julie Dubourg, MD
Poxel SA
STUDY DIRECTOR
Pascale Fouqueray, MD, PhD
Poxel SA
STUDY DIRECTOR

Enrollment

55 participants (actual enrollment reported by the registry).

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 2016

Date type not reported

This date has not been verified as actual or estimated.

NCT06822153

Clinical Trial of the Effect of Methoxyethyl Etomidate Hydrochloride on the QT Interval of the Heart

Phase 1Completed

NCT03618316

Effect of Cimetidine on the PK of Imeglimin

Phase 1Completed

NCT03646331

Bioequivalence of Imeglimin Tablet Formulations

Phase 1Completed

NCT04005027

Exercise Induced QT Interval Changes in Response to Intermittent and Continuous Graded Exercise Tests

Not ApplicableSuspended

NCT03802786

Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

Phase 1Completed

NCT03577275

A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval

Phase 1Completed

Moxifloxacin

ACTIVE COMPARATOR

Tablet, oral, single dose (400 mg)

Drug: Moxifloxacin

MoxifloxacinDrug

Moxifloxacin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Contact the study team to confirm eligibility.

Primary Completion

December 2016

Actual (reported)

Study Completion

December 2016

Actual (reported)

Last Updated

February 10, 2017

Record last verified: 2017-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02924337
Data provider: ClinicalTrials.gov
Source updated: 2017-02-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:14 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Imeglimin therapeutic dose

Imeglimin supratherapeutic dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Moxifloxacin

You may not qualify if:

Source record

Locations