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NCT06368986CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 18 Feb 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
60 (actual)
First submitted
11 Apr 2024
Start date
17 Apr 2024
Primary completion date
2 Oct 2024
Lead sponsor
ViiV Healthcare
Diseases
HIV
NCT number
NCT06368986

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 60
  • From 17 Apr 2024 to the primary completion date, 2 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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.
  • 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.
  • 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.

Lab values

  • ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum creatinine clearance \<60 mL/min.

Other

  • Abnormal blood pressure.
  • Participants who are breastfeeding or plan to become pregnant during the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.