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The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK4532990 Dose 1 | Experimental | Participants will receive GSK4532990 Dose 1 |
|
| GSK4532990 Dose 2 | Experimental | Participants will receive GSK4532990 Dose 2 |
|
| GSK4532990 Dose 3 | Experimental | Participants will receive GSK4532990 Dose 3 |
|
| GSK4532990 Dose 4 | Experimental | Participants will receive GSK4532990 Dose 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4532990 | Drug | GSK4532990 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels | Baseline (Day 1) and up to Week 28 | |
| Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels | Baseline (Day 1) and up to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 | Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose | |
| Maximum observed concentration (Cmax) of GSK4532990 |
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Inclusion Criteria:
Exclusion Criteria:
Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chula Vista | California | 91911 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose |
| Percent change from baseline in the. observed HSD17B13 protein expression. levels | Baseline and Weeks 8, 12, or 28 post-dose |
| Percent change from baseline in the. observed HSD17B13 mRNA expression. levels | Baseline and Weeks 8, 12, or 28 post-dose |
| Montclair |
| California |
| 91763 |
| United States |
| GSK Investigational Site | San Diego | California | 91911 | United States |
| GSK Investigational Site | San Diego | California | 91942 | United States |
| GSK Investigational Site | Brandon | Florida | 33511 | United States |
| GSK Investigational Site | Miami | Florida | 33155 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Miami Lakes | Florida | 33014 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | El Dorado | Kansas | 67042 | United States |
| GSK Investigational Site | Marrero | Louisiana | 70072 | United States |
| GSK Investigational Site | Austin | Texas | 78745 | United States |
| GSK Investigational Site | San Antonio | Texas | 78215 | United States |
| GSK Investigational Site | San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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