The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
VH4011499 administered in fasted or fed conditions.
VH4011499 Dose B administered in fasted or fed conditions.
GSK Investigational Site
Austin, Texas, United States
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499
Time frame: 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
Time frame: From Day 1 (pre-dose) to Day 28
Maximum observed plasma drug concentration (Cmax) of VH4011499
Time frame: From Day 1 (pre-dose) to Day 28
Time to maximum observed plasma concentration (Tmax) of VH4011499
Time frame: From Day 1 (pre-dose) to Day 28
Number of participants with AEs (Adverse Events), by severity
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.
Time frame: From Day 1 (pre-dose) to Day 28
Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
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.
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Time frame: From Day 1 (pre-dose) to Day 28
Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)
Time frame: From Day 1 (pre-dose) to Day 28
Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
Time frame: From Day 1 (pre-dose) to Day 28