Clinical trial NCT06368986: A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants
Official title: An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Fasted condition
Fed condition
Bioavailability
Capsid inhibitor
VH4011499
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.


Eligibility criteria: 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 consent.
* Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.

Exclusion Criteria:

* History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
* Current or chronic liver disease, hepatic or biliary abnormalities, or relevant hepatitis.
* Abnormal blood pressure.
* Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. Participants with exclusionary electrocardiogram findings.Positive HIV test or ongoing behaviors that put the participant at high risk for HIV acquisition.
* Participants who are breastfeeding or plan to become pregnant during the study.
* Past or intended use of exclusionary medications or vaccines.
* Exposure to \>4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
* ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum creatinine clearance \<60 mL/min.
* History of or current infection with hepatitis B or hepatitis C.
* Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
* Positive HIV antibody test.
* Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.

Primary outcomes:
measure: Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499
timeFrame: From Day 1 (pre-dose) to Day 28
measure: 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
timeFrame: From Day 1 (pre-dose) to Day 28
measure: Maximum observed plasma drug concentration (Cmax) of VH4011499
timeFrame: From Day 1 (pre-dose) to Day 28
measure: Time to maximum observed plasma concentration (Tmax) of VH4011499
timeFrame: From Day 1 (pre-dose) to Day 28
Secondary outcomes:
measure: Number of participants with AEs (Adverse Events), by severity
timeFrame: From Day 1 (pre-dose) to Day 28
measure: Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
timeFrame: From Day 1 (pre-dose) to Day 28
measure: Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)
timeFrame: From Day 1 (pre-dose) to Day 28
measure: Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
timeFrame: From Day 1 (pre-dose) to Day 28
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
References: