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This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Regimen A | Experimental | VH4004280 Formulation A tablet administered in fed conditions. |
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| Part 1 - Regimen B | Experimental | VH4004280 Formulation B tablet administered in fed conditions. |
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| Part 1 - Regimen C | Experimental | VH4004280 Formulation C tablet administered in fed conditions. |
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| Part 1 - Optional Regimen D | Experimental | VH4004280 Formulation D tablet administered in fed conditions. |
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| Part 1 - Optional Regimen E | Experimental | VH4004280 Formulation E tablet administered in fed conditions. |
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| Part 2 - Regimen A | Experimental | VH4004280 Formulation A tablet administered in fasted conditions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4004280 Formulation A | Drug | Oral administration of VH4004280 Formulation A in fasted or fed conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal) | From Day 1 to Day 49 | |
| Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4004280 in fed conditions (after a high-fat or lower-fat meal) | From Day 1 to Day 49 | |
| Maximum observed plasma drug concentration (Cmax) of VH4004280 in fed conditions(after a high-fat or lower-fat meal) | From Day 1 to Day 49 | |
| Time to maximum observed plasma concentration (Tmax) of VH4004280 in fed conditions (after a high-fat or lower-fat meal) | From Day 1 to Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs (Adverse Events), by severity | An AE is any untoward medical occurrence in a participant or clinical investigation participant and can be any sign, symptom, or disease temporally associated with the use of a medicinal product. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nottingham | NG11 6JS | United Kingdom |
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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| Part 2- Optional Regimen 1 | Experimental | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
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| Part 2- Optional Regimen 2 | Experimental | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
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| Part 2- Optional Regimen 3 | Experimental | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
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| Part 3 - Optional Regimen 1 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
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| Part 3- Optional Regimen 2 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
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| Part 3 - Optional Regimen 3 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
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| Part 3 - Optional Regimen 4 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
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| VH4004280 Formulation B | Drug | Oral administration of VH4004280 Formulation B in fasted or fed conditions. |
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| VH4004280 Formulation C | Drug | Oral administration of VH4004280 Formulation C in fasted or fed conditions. |
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| VH4004280 Formulation D | Drug | Oral administration of VH4004280 Formulation D in fasted or fed conditions. |
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| VH4004280 Formulation E | Drug | Oral administration of VH4004280 Formulation E in fasted or fed conditions. |
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| From Day 1 to Day 49 |
| Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters | The assessed laboratory assessments include Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), direct bilirubin and total bilirubin, in both fed and fasted conditions. | From Day 1 to Day 49 |
| Change from baseline in liver panel parameters: Total bilirubin and direct bilirubin (micromoles per liter) | From Day 1 to Day 49 |
| Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter) | From Day 1 to Day 49 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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