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The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg. Part B was an optional part to test once-daily doses of the study medicine in healthy volunteers. We aimed to assess the safety, tolerability find out the side effects and blood levels of the PXL770.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PXL770 500 and 750 mg | Experimental | Each subject received 1 dose of PXL770 at 500 mg and 1 dose at 750 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXL770 | Drug | A single dose of 500 and 750 mg was administered to each subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum concentration | Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |
| AUC | area under the curve | Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |
| t1/2 | half-life | Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |
| tmax | time to reach maximum concentration | Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |
| MRT | mean residence time | Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |
| CL/F | apparent clearance | Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |
| Vz/F |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Adverse events | Safety monitoring will be done from the date of signature of the ICF until the end of the study, assessed up to 5 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HMR | London | NW10 | 7EW | United Kingdom |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System 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 |
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volume of distribution
| Blood samples for assay of PXL770 will be taken at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours after each dose. |