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NCT02373150
A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects
Phase 1 trial testing Imeglimin in Type 2 Diabetes Mellitus in 48 participants. Completed in 1 October 2015.
1 October 2015
Quick facts
| Lead sponsor | Poxel SA |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 February 2015 |
| Primary completion | 1 October 2015 |
| Estimated completion | 1 October 2015 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Imeglimin (IMEGLIMIN) — full drug profile →
- Placebo
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Poxel SA — full company profile →
Who can join
Adults 20 to 45, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin
Time frame: From baseline to Day 13
* Cmax: peak plasma concentration after dosing * AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time * AUC0-t: area under the concentration-time curve from 0 to the time of last quantifiable concentration * Tmax: time of peak plasma concentration of imeglimin -
Safety and tolerability of imeglimin: laboratory assessments
Time frame: From baseline to Day 13
* routine hematology, biochemistry, coagulation and urinalysis * physical examination * 12-lead ECG * vital signs * capillary glucose * incidence of adverse events
Sponsor's own description
This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02373150
- 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 recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
- NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
- NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
- NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
- NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
- NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting
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 NCT02373150 (US National Library of Medicine, public domain)
- 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/NCT02373150.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing