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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
Phase 1 trial testing Placebo in Qt Interval, Variation in in 55 participants. Completed in 1 December 2016.
1 December 2016
Quick facts
| Lead sponsor | Poxel SA |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 September 2016 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Placebo
- Imeglimin (IMEGLIMIN) — full drug profile →
- Moxifloxacin (moxifloxacin) — full drug profile →
Conditions studied
- Qt Interval, Variation in — all drugs for Qt Interval, Variation in →
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.
-
Change from baseline in QTcF (deltaQTcF)
Time frame: Up to 24 hours
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):
-
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
Verify or expand the search:
- PubMed search for NCT02924337
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Imeglimin
Trials testing the same drug.
- NCT07436182 — Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. · Phase 4 · not yet recruiting
- NCT05366868 — Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus · Phase 4 · active not recruiting
- NCT03802786 — Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects · Phase 1 · completed
- NCT03646331 — Bioequivalence of Imeglimin Tablet Formulations · Phase 1 · completed
- NCT03618316 — Effect of Cimetidine on the PK of Imeglimin · Phase 1 · completed
Other Poxel SA trials
Trials by the same sponsor.
- NCT05441904 — Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects. · Phase 1 · completed
- NCT04321343 — Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · completed
- NCT03950882 — A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD · Phase 1 · completed
- NCT03763877 — A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD · Phase 2 · completed
- NCT03886103 — Pharmacokinetics and Metabolism of (14C)-Labelled PXL770 · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02924337 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poxel SA
- Last refreshed: 9 February 2017
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