HIV Infections
Conditions
Keywords
Fasted condition, Fed condition, Bioavailability, Capsid inhibitor, VH4011499
Brief summary
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
Interventions
DRUGVH4011499 Dose A
VH4011499 administered in fasted or fed conditions.
DRUGVH4011499 Dose B
VH4011499 Dose B administered in fasted or fed conditions.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 birth who are of childbearing potential must be using acceptable forms of birth control.
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 relevant hepatitis. * Abnormal blood pressure. * 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. * 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 participation in this study, or current enrolment or participation in another investigational study. * ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum 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, or contact with known COVID-19 positive person. * Positive HIV antibody test. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to maximum observed plasma concentration (Tmax) of VH4011499 | From Day 1 (pre-dose) to Day 28 |
| Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499 | From Day 1 (pre-dose) to Day 28 |
| 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 VH4011499 | From Day 1 (pre-dose) to Day 28 |
| Maximum observed plasma drug concentration (Cmax) of VH4011499 | From Day 1 (pre-dose) to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs (Adverse Events), by severity | From Day 1 (pre-dose) to Day 28 | An AE is any untoward medical occurrence in a participant or clinical investigation participant and can be any sign, symptom, or disease temporally associated with the use of a medicinal product. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death, Grade 5 = death. |
| Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters | From Day 1 (pre-dose) to Day 28 | The assessed laboratory assessments include Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), direct bilirubin and total bilirubin, in both fed and fasted conditions. |
| Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter) | From Day 1 (pre-dose) to Day 28 | — |
| Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter) | From Day 1 (pre-dose) to Day 28 | — |
Countries
United States
Outcome results
None listed