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

Last updated: February 13, 2025
Sponsor: ViiV Healthcare
Overall Status: Completed

Phase

1

Condition

Hiv Infections

Treatment

VH4011499

VH4011499 Dose A

VH4011499 Dose B

Clinical Study ID

NCT06368986
222420
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 birthwho are of childbearing potential must be using acceptable forms of birth control.

Exclusion

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 relevanthepatitis.

  • Abnormal blood pressure.

  • Any malignancy within the past 5 years except certain localized malignancies, orbreast cancer within the past 10 years. Participants with exclusionaryelectrocardiogram findings.Positive HIV test or ongoing behaviors that put theparticipant 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 participationin this study, or current enrolment or participation in another investigationalstudy.

  • ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimatedserum 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, orcontact with known COVID-19 positive person.

  • Positive HIV antibody test.

  • Participants with positive results for illicit drug use, regular use of drugs ofabuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: VH4011499
Phase: 1
Study Start date:
April 17, 2024
Estimated Completion Date:
October 02, 2024

Connect with a study center

  • GSK Investigational Site

    Austin, Texas 78744 -1645
    United States

    Site Not Available

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