NCT06168318CompletedPhase 1
A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants
A 3-part, Phase 1, Single-center, Open-label Study to Assess the Relative Bioavailability of Oral Formulations for an Investigational Capsid Inhibitor in Healthy Adult Participants, and to Evaluate the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
Source: ClinicalTrials.gov · Last updated 2 Aug 2024
Brief summary (registry, in English)
This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 4 Dec 2023
- Start date
- 18 Dec 2023
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT06168318
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 46
- From 18 Dec 2023 to the primary completion date, 3 Jun 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 \> 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.
- Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
- Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- 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 with exclusionary electrocardiogram findings.
Who the study is looking for
- Participants must be 18 to 55years of age.
- Participants who are overtly healthy.
- Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
- Has body mass index (BMI) within the range 19-32 (kg/m2).
- 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.
- Capable of giving signed informed consent.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.