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PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Experimental | Dose 1 or placebo |
|
| Group A2 | Experimental | Dose 2 or placebo |
|
| Group A3 | Experimental | Dose 3 or placebo |
|
| Group A4 | Experimental | Dose 4 or placebo |
|
| Group A5 | Experimental | Dose 5 or placebo |
|
| Group B | Experimental | Dose + Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXL770 | Drug | MAD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770 | - Cmax: peak plasma concentration after dosing | From baseline to day 14 |
| Part A: PK parameters of PXL770 after repeated doses | - AUC0-t: area under the concentration-time curve from 0 extrapolated to time t | From baseline to day 14 |
| Part A: PK parameters of PXL770 after repeated doses | - AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite | From baseline to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of treatment emergent adverse events | From baseline to day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | London | United Kingdom |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000719997 | 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 |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Placebo | Drug | MAD |
|
| Rosuvastatin | Drug | DDI |
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |