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The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose A - Fasted condition | Experimental | VH4011499 Dose A tablet administered in fasted condition. |
|
| Part 1 Dose A- Fed condition (high fat meal) | Experimental | VH4011499 Dose A tablet administered in fed condition (high fat meal). |
|
| Part 2 Dose B - Optional - Fed condition (low fat meal) | Experimental | VH4011499 Dose B tablet administered in fed condition (low fat meal). |
|
| Part 3 Dose B - Fasted condition | Experimental | VH4011499 Dose B tablet administered in fasted condition. |
|
| Part 3 Dose B - Fed condition (high fat meal) | Experimental | VH4011499 Dose B tablet administered in fed condition (high fat meal). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4011499 Dose A | Drug | VH4011499 administered in fasted or fed conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499 | From Day 1 (pre-dose) to Day 28 | |
| 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 VH4011499 | From Day 1 (pre-dose) to Day 28 | |
| Maximum observed plasma drug concentration (Cmax) of VH4011499 | From Day 1 (pre-dose) to Day 28 | |
| Time to maximum observed plasma concentration (Tmax) of VH4011499 | From Day 1 (pre-dose) to Day 28 |
| 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, Grade 5 = death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 -1645 | United States |
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 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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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| VH4011499 Dose B | Drug | VH4011499 Dose B administered in fasted or fed conditions. |
|
| From Day 1 (pre-dose) to Day 28 |
| 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 (pre-dose) to Day 28 |
| Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter) | From Day 1 (pre-dose) to Day 28 |
| Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter) | From Day 1 (pre-dose) to Day 28 |
| 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 |