This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
GSK Investigational Site
Baltimore, Maryland, United States
Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)
Time frame: Up to 4 weeks
Part 2: Number of participants with SAE and non-SAE
Time frame: Up to 6.5 weeks
Part 3: Number of participants with SAE and non-SAE
Time frame: Up to 6.5 weeks
Part 1: Number of participants with adverse events based on severity
Time frame: Up to 4 weeks
Part 2: Number of participants with adverse events by severity
Time frame: Up to 6.5 weeks
Part 3: Number of participants with adverse events based on severity
Time frame: Up to 6.5 weeks
Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)
Time frame: Up to 4 weeks
Part 2: Percentage of participants who discontinue treatment due to AE
Time frame: Up to 6.5 weeks
Part 3: Percentage of participants who discontinue treatment due to AE
Time frame: Up to 6.5 weeks
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in INR (Ratio)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in INR (Ratio)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Number of participant with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: Area under the plasma concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tau]) following dosing of VH4524184
Time frame: Up to 6.5 weeks
Part 1: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: Cmax following dosing of VH4524184
Time frame: Up to 6.5 weeks
Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: Tmax following dosing of VH4524184
Time frame: Up to 6.5 weeks
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: T1/2 following dosing of VH4524184
Time frame: Up to 6.5 weeks
Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: Up to 4 weeks
Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: Up to 6.5 weeks
Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: Up to 6.5 weeks