This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GSK4347859 in healthy participants. Part 1 consists of 2 planned cohorts with up to 4 treatment periods in each and is expected to have up to 8 dose levels. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
GSK4347859 will be administered
Placebo will be administered
GSK Investigational Site
Cambridge, United Kingdom
GSK Investigational Site
Nottingham, United Kingdom
Part 1 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 15
Part 2 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 30
Part 1 - Number of Participants with Clinically Significant Changes in Haematology
Time frame: Up to Day 15
Part 2 - Number of Participants with Clinically Significant Changes in Haematology
Time frame: Up to Day 30
Part 1 - Number of Participants with Clinically Significant Changes in Clinical Chemistry
Time frame: Up to Day 15
Part 2 - Number of Participants with Clinically Significant Changes in Clinical Chemistry
Time frame: Up to Day 30
Part 1 - Number of Participants with Clinically Significant Changes in Laboratory Values for Urinalysis
Time frame: Up to Day 15
Part 2 - Number of Participants with Clinically Significant Changes in Urinalysis
Time frame: Up to Day 30
Part 1 - Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 15
Part 2 - Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 30
Part 1 - Number of Participants with Clinically Significant Changes in 12 Lead Electrocardiogram Readings
Time frame: Up to Day 15
Part 2 - Number of Participants with Clinically Significant Changes in 12 Lead Electrocardiogram Readings
Time frame: Up to Day 30
Part 1 - Number of Participants with Clinically Significant Changes in 24 Hour Telemetry
Time frame: Up to Day 2
Part 2 - Number of Participants with Clinically Significant Changes in 24 Hour Telemetry
Time frame: Up to Day 15
Part 1 - Maximum observed plasma concentration (Cmax) of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Time to maximum observed plasma concentration (Tmax) of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Apparent terminal half-life (t½) of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Area under the concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Area under the concentration-time curve from time zero to infinity [AUC(0-∞)] of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Area under the concentration-time curve over each dosing interval [AUC(0-tau)] of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Area under the concentration-time curve from time zero to 24 hours after dosing [AUC(0-24)] of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 1 - Observed trough concentrations (Ctrough) of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 3
Part 2 - Cmax of GSK3996401 following administration of single and repeat doses of GSK4347859
Time frame: Up to Day 15
Part 2 - Tmax of GSK3996401 following administration of single and repeat doses of GSK4347859
Time frame: Up to Day 15
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Part 2 - Area under the concentration-time curve from time zero to 24 hours after dosing [AUC(0-24)] of GSK3996401 following administration single and repeat doses of GSK4347859
Time frame: Up to Day 15
Part 2 - Observed trough concentrations (Ctrough) of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 15
Part 2 - Area under the concentration-time curve over each dosing interval [AUC(0-tau)] of GSK3996401 following administration of GSK4347859
Time frame: Up to Day 15