Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05999708
Status:
WITHDRAWN
Last Update Posted:
2023-12-15
First Post:
2023-08-11
Brief Title:
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated prior to FSFV for strategic business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None