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Completed

NCT Number: NCT06368986

A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Austin, Texas, 78744 -1645, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VH4011499 Dose A

Drug

VH4011499 administered in fasted or fed conditions.

VH4011499 Dose B

Drug

VH4011499 Dose B administered in fasted or fed conditions.

Primary outcomes

  1. Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499

    Time frame: From Day 1 (pre-dose) to Day 28

  2. 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

    Time frame: From Day 1 (pre-dose) to Day 28

  3. Maximum observed plasma drug concentration (Cmax) of VH4011499

    Time frame: From Day 1 (pre-dose) to Day 28

  4. Time to maximum observed plasma concentration (Tmax) of VH4011499

    Time frame: From Day 1 (pre-dose) to Day 28

Secondary outcomes

  1. Number of participants with AEs (Adverse Events), by severity

    Time frame: From Day 1 (pre-dose) to Day 28

    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.

  2. Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters

    Time frame: From Day 1 (pre-dose) to Day 28

    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.

  3. Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)

    Time frame: From Day 1 (pre-dose) to Day 28

  4. Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)

    Time frame: From Day 1 (pre-dose) to Day 28

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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