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NCT02924337

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

Completed Phase 1 Last updated 9 February 2017
What this trial tests

Phase 1 trial testing Placebo in Qt Interval, Variation in in 55 participants. Completed in 1 December 2016.

Timeline
1 September 2016
Primary endpoint
1 December 2016
1 December 2016

Quick facts

Lead sponsorPoxel SA
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment55
Start date1 September 2016
Primary completion1 December 2016
Estimated completion1 December 2016
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Poxel SA — full company profile →

Who can join

Adults 18 to 45, any sex, with Qt Interval, Variation in. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus.
    Dubourg J, Perrimond-Dauchy S, Felices M, Bolze S, et al · · 2020 · cited 11× · PMID 32556539 · DOI 10.1007/s00228-020-02929-6

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Other trials of Imeglimin

Trials testing the same drug.

Other Poxel SA trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02924337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing