Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PXL770 | Experimental | PXL770 500 mg once daily (QD) for 4 weeks |
|
| Placebo | Placebo Comparator | placebo once daily (QD) for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXL770 | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of PXL770 | AUC : Area under the plasma concentration curve | Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK parameters of PXL770 | Minimum plasma concentration (Cmin) | Day 26 |
| Plasma PK parameters of PXL770 | Average plasma concentration (Cavg) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35028615 | Derived | Fouqueray P, Bolze S, Dubourg J, Hallakou-Bozec S, Theurey P, Grouin JM, Chevalier C, Gluais-Dagorn P, Moller DE, Cusi K. Pharmacodynamic effects of direct AMP kinase activation in humans with insulin resistance and non-alcoholic fatty liver disease: A phase 1b study. Cell Rep Med. 2021 Dec 21;2(12):100474. doi: 10.1016/j.xcrm.2021.100474. eCollection 2021 Dec 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral capsule |
|
| Day 26 |
| Plasma PK parameters of PXL770 | Time to maximum plasma concentration (Tmax) | Day 26 |
| Plasma PK parameters of PXL770 | Apparent volume of distribution (Vz/F) | Day 26 |
| Plasma PK parameters of PXL770 | Apparent oral drug clearance at steady state (CLss/F) | Day 26 |
| Plasma PK parameters of PXL770 | Elimination rate constant (λz) | Day 26 |
| Plasma PK parameters of PXL770 | Terminal elimination half-life (t½) | Day 26 |
| Plasma PK parameters of PXL770 | Area under the concentration-time curve from time 0 to last observed concentration (AUClast) | Day 26 |
| Plasma PK parameters of PXL770 | Food effect: Cmax | Day 14 and Day 26 |
| Plasma PK parameters of PXL770 | Food effect: AUCtau | Day 14 and Day 26 |
| Plasma PK parameters of PXL770 | Food effect: Tmax | Day 14 and Day 26 |
| Plasma PK parameters of PXL770 | PK profile during OGTT: AUCtau | Day 27 |
| Plasma PK parameters of PXL770 | PK profile during OGTT: Cmax | Day 27 |