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This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Moderate (CP-B) hepatic impairment | Experimental |
| |
| Participants with Mild (CP-A) hepatic impairment | Experimental |
| |
| Healthy participants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3228836 | Drug | GSK3228836 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)] | Up to Day 50 post-dose | |
| Maximum observed concentration (Cmax) | Up to Day 50 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC from time zero (pre-dose) to 24 hours [AUC(0-24)] | Up to 24 hours post-dose | |
| AUC from time zero (pre-dose) to 168 hours [AUC(0-168)] | Up to 168 hours post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Orlando | Florida | 32809 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Plasma concentration of GSK3228836 on Day 8 |
| Day 8 post-dose |
| Apparent terminal phase half-life (t1/2) | Up to Day 50 post-dose |
| Apparent clearance (CL/F) | Up to Day 50 post-dose |
| Time of occurrence of Cmax (Tmax) | Up to Day 50 post-dose |
| Apparent terminal phase volume of distribution (Vz/F) | Up to Day 50 post-dose |
| San Antonio |
| Texas |
| 78215 |
| United States |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |