12 completed, 2 withdrawn. 9 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 9 |
| Phase 2 | 5 | Completed 3, Withdrawn 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Assess PXL065 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD) PXL065 - ALD (Adrenoleukodystrophy) | Phase 2 | Withdrawn | Poxel SA | 2023-09-01 | 2024-12-16 | |
| Study to Assess PXL770 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD) PXL770 - Adrenomyeloneuropathy | Phase 2 | Withdrawn | Poxel SA | 2023-09-01 | 2024-12-16 | |
| Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects. PXL770 - NASH - Nonalcoholic Steatohepatitis | Phase 1 | Completed | Poxel SA | 16 | 2021-03-08 | 2022-07-01 |
| Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) PXL065, Placebo oral tablet - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Poxel SA | 117 | 2020-09-01 | 2023-08-29 |
| A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD PXL770, Placebo - Nonalcoholic Fatty Liver | Phase 1 | Completed | Poxel SA | 17 | 2019-08-01 | 2021-06-11 |
| A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD PXL770, Placebo Oral Capsule - Nonalcoholic Fatty Liver | Phase 2 | Completed | Poxel SA | 121 | 2019-03-29 | 2021-10-28 |
| Pharmacokinetics and Metabolism of (14C)-Labelled PXL770 14C labeled PXL770 - Healthy | Phase 1 | Completed | Poxel SA | 8 | 2019-02-06 | 2019-03-22 |
| Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects Imeglimin - Hepatic Impairment | Phase 1 | Completed | Poxel SA | 14 | 2018-11-06 | 2020-08-11 |
| Bioequivalence of Imeglimin Tablet Formulations Imeglimin Reference product, Imeglimin - Bioequivalence | Phase 1 | Completed | Poxel SA | 16 | 2018-09-03 | 2019-01-11 |
| Effect of Cimetidine on the PK of Imeglimin Imeglimin, Cimetidine - Healthy | Phase 1 | Completed | Poxel SA | 16 | 2018-06-19 | 2018-08-27 |
| Safety, Tolerability and PK of PXL770 in Healthy Male Subjects PXL770, Placebo, Rosuvastatin - Metabolic Disease | Phase 1 | Completed | Poxel SA | 60 | 2017-08-21 | 2018-08-24 |
| Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects Placebo, Imeglimin, Moxifloxacin - Qt Interval, Variation in | Phase 1 | Completed | Poxel SA | 55 | 2016-09-01 | 2017-02-10 |
| Safety, Tolerability and PK of Imeglimin in Japanese Volunteers Imeglimin, Placebo - Type 2 Diabetes Mellitus | Phase 1 | Completed | Poxel SA | 48 | 2015-02-01 | 2017-02-10 |
| A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Imeglimin, Placebo - Type 2 Diabetes Mellitus | Phase 2 | Completed | Poxel SA | 315 | 2013-01-01 | 2015-08-13 |
Non-alcoholic Fatty Liver Disease (4) · Adrenoleukodystrophy (2) · Diabetes Mellitus, Type 2 (2) · Metabolic Diseases (1)
imeglimin (6) · 2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-7H-thieno)(2,3-b)pyridin-4-olate potassium (5) · Cimetidine (1) · Moxifloxacin (1) · Rosuvastatin Calcium (1)
United Kingdom (7) · United States (3) · Germany (1) · Latvia (1)
Julie Dubourg, MD (1) · Pascale Fouqueray, MD, PhD (1) · Valdis Pirags, MD (1)
PMID 32556539, PMID 34560015, PMID 35028615
2016 (1)