NCT05999708

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled, Single, Repeat Dose Escalation and Indomethacin Challenge Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK4381406 in Healthy Participants

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	GSK4381406	GSK4381406 will be administered.
DRUG	Placebo	Placebo will be administered.
DRUG	Indomethacin	Indomethacin will be administered.

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2023-08-21
• Last updated: 2023-12-15

Locations

1 site across 1 country: United Kingdom