Clinical trial NCT06168318: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Human immunodeficiency virus
HIV-1
capsid inhibitor
VH4004280
food effect
fasted conditions
fed conditions
bioavailability
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Participants must be 18 to 55years of age.
2. Participants who are overtly healthy.
3. Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
4. Has body mass index (BMI) within the range 19-32 (kg/m2).
5. 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.
6. Capable of giving signed informed consent.

Exclusion Criteria:

1. History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
2. Abnormal blood pressure.
3. Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
4. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
6. Participants with exclusionary electrocardiogram findings.
7. Past or intended use of exclusionary medications or vaccines.
8. Exposure \> 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
9. ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum creatinine clearance \<60 mL/min.
10. History of or current infection with hepatitis B or hepatitis C.
11. Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
12. Positive HIV antibody test.
13. 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: Time to maximum observed plasma concentration (Tmax) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
timeFrame: From Day 1 to Day 49
Secondary outcomes:
measure: Number of participants with AEs (Adverse Events), by severity
timeFrame: From Day 1 to Day 49
measure: Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
timeFrame: From Day 1 to Day 49
measure: Change from baseline in liver panel parameters: Total bilirubin and direct bilirubin (micromoles per liter)
timeFrame: From Day 1 to Day 49
measure: Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
timeFrame: From Day 1 to Day 49
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: