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VH4011499 Dose A

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Feb 18, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

VH4011499 Dose A · 1 trial · 1 indication

Phase 1 1
NCT06368986A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy ParticipantsHIV Infections
COMPLETED60 Analytics
PHASE1COMPLETED
A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Number of participants with AEs (Adverse Events), by severity
From Day 1 (pre-dose) to Day 28
Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Part 1 Dose A - Fasted conditionEXPERIMENTALVH4011499 Dose A tablet administered in fasted condition.
Part 1 Dose A- Fed condition (high fat meal)EXPERIMENTALVH4011499 Dose A tablet administered in fed condition (high fat meal).
Part 2 Dose B - Optional - Fed condition (low fat meal)EXPERIMENTALVH4011499 Dose B tablet administered in fed condition (low fat meal).
Part 3 Dose B - Fasted conditionEXPERIMENTALVH4011499 Dose B tablet administered in fasted condition.
Part 3 Dose B - Fed condition (high fat meal)EXPERIMENTALVH4011499 Dose B tablet administered in fed condition (high fat meal).

Interventions

NameTypeDescription
VH4011499 Dose ADRUGVH4011499 administered in fasted or fed conditions.
VH4011499 Dose BDRUGVH4011499 Dose B administered in fasted or fed conditions.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who are 18 to 55 years of age. * Participants who are overtly healthy. * One SARs-CoV-2 negative test is required prior to dosing * Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive). * Capable of giving signed informed...

Countries:United States
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Frequently asked questions about VH4011499 Dose A

What is VH4011499 Dose A used for?

VH4011499 Dose A is an investigational small molecule being studied for the treatment of HIV infections. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in clinical trials to assess its safety and pharmacokinetics.

Who makes VH4011499 Dose A?

VH4011499 Dose A is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's potential as a treatment for HIV infections.

What phase is VH4011499 Dose A in?

VH4011499 Dose A is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The drug is being studied in healthy volunteers to evaluate its safety and how it is processed by the body.

What clinical trials is VH4011499 Dose A in?

VH4011499 Dose A has been studied in one completed Phase 1 clinical trial, identified as NCT06368986. This trial, conducted in the United States, enrolled 60 healthy participants to investigate the effect of food on the bioavailability of a capsid inhibitor (CAI) in male and female healthy participants.

How does VH4011499 Dose A work?

VH4011499 Dose A is a small molecule that acts as a capsid inhibitor (CAI). It is being developed to target HIV infections by interfering with the viral capsid, a protein shell that protects the viral genetic material. This mechanism is intended to disrupt the virus's ability to replicate and infect cells.