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Capsid Inhibitor

Part 1- Fasted condition for Human Immunodeficiency Virus Infection

Phase 1
Recruiting
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive)
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
Must not have
Unstable liver disease, known biliary abnormalities, known history of cirrhosis, clinically relevant hepatitis within last 6 months, chronic hepatitis B infection, abnormal blood pressure, lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin, breast cancer within the past 10 years, current or chronic history of liver disease or known hepatic or biliary abnormalities, QT interval corrected for heart rate >450 msec, history of or on-going high-risk behaviors for HIV acquisition, previous participation in study 222420, breastfeeding or plan to become pregnant during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 (pre-dose) to day 28
Awards & highlights

Summary

"This trial is looking at how different types of food (fasted or fed conditions) affect how the body absorbs CAI VH4011499."

Who is the study for?
This trial is for healthy men and women aged 18-55, weighing between 50-100 kg with a BMI of 19-32. Participants must test negative for SARs-CoV-2 before dosing, agree to use contraception methods through Day 28, and not be pregnant or breastfeeding if female.
What is being tested?
The study is testing the bioavailability (how well the body absorbs) of a Capsid Inhibitor (CAI), VH4011499, when taken with or without food by healthy participants.
What are the potential side effects?
As this summary focuses on the design and eligibility criteria of the clinical trial rather than specific treatment details, side effects are not provided here. Typically, potential side effects would be outlined in detail within the informed consent documents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 50-100 kg and my BMI is between 19-32.
Select...
I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 (pre-dose) to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (pre-dose) to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499
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
Maximum observed plasma drug concentration (Cmax) of VH4011499
+1 more
Secondary outcome measures
Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)
Number of participants with AEs (Adverse Events), by severity
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2 - Optional - Fed condition (lower fat meal)Experimental Treatment1 Intervention
VH4011499 tablet administered in fed condition (lower fat meal).
Group II: Part 1- Fed condition (high fat meal)Experimental Treatment1 Intervention
VH4011499 tablet administered in fed condition (high fat meal).
Group III: Part 1- Fasted conditionExperimental Treatment1 Intervention
VH4011499 tablet administered in fasted condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VH4011499
2022
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
363 Previous Clinical Trials
468,952 Total Patients Enrolled
~24 spots leftby Sep 2025
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