A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants
Status:
Withdrawn
Trial end date:
2024-12-05
Target enrollment:
Participant gender:
Summary
This is a 3-part First Time in Human (FTIH) study to evaluate the safety, tolerability, and
pharmacokinetics (PK) profile of GSK4381406 following administration of single ascending
doses (Part 1), repeat ascending doses (Part 2), and repeat doses with an indomethacin
challenge (Part 3) in healthy adult participants. Part 1 consists of 4 planned cohorts with
up to 2 treatment periods in each and is expected to have 6 doses (but can accommodate up to
7 doses). The impact of food on PK of GSK4381406 will also be assessed. Part 2 will
investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels. Part 3 will evaluate
the impact of repeat doses of GSK4381406 versus placebo on indomethacin induced changes in
small intestinal permeability in healthy participants.