NCT05999708 is a Phase 1 clinical trial of GSK4381406 in Colitis, Ulcerative, sponsored by GlaxoSmithKline.

Who is sponsoring NCT05999708?

NCT05999708 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT05999708?

Interventions in NCT05999708: GSK4381406, Placebo, Indomethacin.

What condition does NCT05999708 study?

NCT05999708 studies Colitis, Ulcerative.

Is NCT05999708 still recruiting?

NCT05999708 is currently withdrawn. Last updated 15 December 2023.

Last reviewed 2023-12-15 · How we verify

NCT05999708

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 1 Last updated 15 December 2023

What this trial tests

Phase 1 trial testing GSK4381406 in Colitis, Ulcerative. Withdrawn.

Timeline

31 October 2023

Primary endpoint
5 December 2024

5 December 2024

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Start date	31 October 2023
Primary completion	5 December 2024
Estimated completion	5 December 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

GSK4381406 — full drug profile →
Placebo
Indomethacin (INDOMETHACIN) — full drug profile →

Conditions studied

Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

GPR35-mediated metabolic reprogramming promotes tumorigenesis in digestive cancers.
Wang F, Ding XX, Su TH, Cao J, et al · · 2025 · PMID 41459506 · DOI 10.3389/fimmu.2025.1668471

Verify or expand the search:

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col · Phase 3 · recruiting
NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05999708 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 15 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05999708.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing