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VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: VH4770359 SAD group | Experimental | Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD). |
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| Part A: Placebo SAD group | Placebo Comparator | Healthy participants will receive a single dose of Placebo on Day 1. |
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| Part B: VH4770359 MAD group | Experimental | Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD). |
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| Part B: Placebo MAD group | Placebo Comparator | Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. |
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| Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group | Experimental | Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4770359 | Drug | Participants will receive the assigned dose formulation of VH4770359 orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Grade 3 and Grade 4 adverse events (AEs) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity. | From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration | AUC(0-inf) is calculated using a standard non-compartmental analysis. | At Day 1 (pre-dose, 0.5h 1h, 2h, 3h, 4h, 6h, 8h,12h), Day 2 (24h, 36h), Day 3, Day 4, Day 5, Day 6, Day 7 and during outpatient visits until the last on site study visit (up to approximately 9 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
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 asset(s) with development terminated 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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| 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 |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Double-blind.
| Part B: Placebo MAD DDI group | Placebo Comparator | Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
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| Placebo | Drug | Participants will receive placebo to match the VH4770359 dose formulation. |
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| Midazolam | Drug | Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
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| Part B: AUC over a single dosing interval from time 0 to the next dose (AUC[0-tau]) of VH4770359 following multiple dose administration | AUC(0-tau) is calculated using a standard non-compartmental analysis. | At Day 1 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) and at Day 14 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) |
| 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 |
| D006571 | Heterocyclic Compounds |