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VH4004280 Formulation A

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 2, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

VH4004280 Formulation A · 1 trial · 1 indication

Phase 1 1
NCT06168318A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy ParticipantsHIV Infections
COMPLETED46 Analytics
PHASE1COMPLETED
A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations 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 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

Secondary Endpoints

Number of participants with AEs (Adverse Events), by severity
From Day 1 to Day 49
Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - Regimen AEXPERIMENTALVH4004280 Formulation A tablet administered in fed conditions.
Part 1 - Regimen BEXPERIMENTALVH4004280 Formulation B tablet administered in fed conditions.
Part 1 - Regimen CEXPERIMENTALVH4004280 Formulation C tablet administered in fed conditions.
Part 1 - Optional Regimen DEXPERIMENTALVH4004280 Formulation D tablet administered in fed conditions.
Part 1 - Optional Regimen EEXPERIMENTALVH4004280 Formulation E tablet administered in fed conditions.
Part 2 - Regimen AEXPERIMENTALVH4004280 Formulation A tablet administered in fasted conditions.
Part 2- Optional Regimen 1EXPERIMENTALVH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.
Part 2- Optional Regimen 2EXPERIMENTALVH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.
Part 2- Optional Regimen 3EXPERIMENTALVH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.
Part 3 - Optional Regimen 1EXPERIMENTALVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Part 3- Optional Regimen 2EXPERIMENTALVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Part 3 - Optional Regimen 3EXPERIMENTALVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Part 3 - Optional Regimen 4EXPERIMENTALVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.

Interventions

NameTypeDescription
VH4004280 Formulation ADRUGOral administration of VH4004280 Formulation A in fasted or fed conditions.
VH4004280 Formulation BDRUGOral administration of VH4004280 Formulation B in fasted or fed conditions.
VH4004280 Formulation CDRUGOral administration of VH4004280 Formulation C in fasted or fed conditions.
VH4004280 Formulation DDRUGOral administration of VH4004280 Formulation D in fasted or fed conditions.
VH4004280 Formulation EDRUGOral administration of VH4004280 Formulation E in fasted or fed conditions.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Participants must be 18 to 55years of age. 2. Participants who are overtly healthy. 3. Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing. 4. Has body mass index (BMI) within the range 19-32 (kg/m2). 5. Participants male at birth must u...

Countries:United Kingdom
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Frequently asked questions about VH4004280 Formulation A

What is VH4004280 Formulation A used for?

VH4004280 Formulation A is an investigational small molecule being developed for HIV Infections. It is currently in Phase 1 clinical development and is not approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its pharmacokinetic properties.

What does VH4004280 Formulation A target?

VH4004280 Formulation A is an oral capsid inhibitor, meaning it targets the HIV capsid protein. By inhibiting the capsid, the drug aims to disrupt multiple steps of the HIV replication cycle. This mechanism is being investigated as a potential treatment for HIV Infections.

Who makes VH4004280 Formulation A?

VH4004280 Formulation A is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy participants.

What phase is VH4004280 Formulation A in?

VH4004280 Formulation A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for HIV Infections.

What clinical trials is VH4004280 Formulation A in?

VH4004280 Formulation A has one completed clinical trial, NCT06168318. This Phase 1 study investigated the relative bioavailability and food effect of an oral capsid inhibitor tablet formulation compared with other oral tablet formulations in healthy participants. The trial enrolled 46 participants in the United Kingdom.

Is VH4004280 Formulation A the same as other oral tablet formulations?

VH4004280 Formulation A is a specific tablet formulation of an oral capsid inhibitor being studied for HIV Infections. The clinical trial NCT06168318 compared this formulation with other oral tablet formulations of the same drug to assess relative bioavailability and food effects.