A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor T… (NCT06168318) | Clinical Trial Compass
CompletedPhase 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
United Kingdom46 participantsStarted 2023-12-18
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
✕. Abnormal blood pressure.
✕. Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
✕
What they're measuring
1
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Timeframe: From Day 1 to Day 49
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 VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Timeframe: From Day 1 to Day 49
3
Maximum observed plasma drug concentration (Cmax) of VH4004280 in fed conditions(after a high-fat or lower-fat meal)
Timeframe: From Day 1 to Day 49
4
Time to maximum observed plasma concentration (Tmax) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
. 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.
✕. Participants with exclusionary electrocardiogram findings.
✕. 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.