A First Time in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK4381406
Research type
Research Study
Full 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
IRAS ID
1007961
Contact name
Tania Mateus
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Research summary
GSK4381406 is a development drug to help patients with common gut disorders like IBS-D (Irritable bowel syndrome) and IBD (Inflammatory bowel disease). These diseases cause frequent bouts of abdominal pain and diarrhoea. Normally, our gut has a working barrier that allows nutrients to cross into the bloodstream and keep harmful substances out. In these diseases, there is damage to this barrier that allows harmful substances to cross the barrier. Despite current treatments, patients only experience a temporary relief of their symptoms. Oral medications that treat pain and decrease diarrhoea are needed.
GSK4381406 binds to a protein (GPR35) on the surface of the cells that form the lining of the gut. Animal studies showed that this binding may restore the barrier function of the gut. GSK4381406 has only been tested in animals. Those studies have shown that most of the drug stays inside the gut and passes out in the faeces. There is a possibility that a small amount of GSK4381406 might move from the gut into the bloodstream.
This is a Single and Multiple Ascending Dose, First in Human study which aims to test if the drug is safe and well-tolerated. It is also designed to assess how much GSK4381406 can pass through the gut into the bloodstream and urine, and how long the body takes to remove it. It will assess how food affects the study drug too. The study tests different doses of GSK4381406 given as a single dose or repeat doses.
A part of the study will involve giving an approved medicine Indomethacin to temporarily increase the amount of sugars that cross this barrier and testing if there is a difference in the barrier function between GSK4381406 and placebo.
This study will involve healthy adults who are between 18 and 55 years old. ‘Approximately 70 participants (up to a maximum of 126) will take part. The total duration of the study will be approximately 12 months’REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0166
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion