GSK3882347 First time in human study
Research type
Research Study
Full title
A Double-Blind Randomized, Placebo-Controlled, Single and Repeated Oral Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics (including food effect) of GSK3882347 in Healthy Participants
IRAS ID
284925
Contact name
Disala Fernando
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2020-000680-23
Duration of Study in the UK
0 years, 8 months, 13 days
Research summary
Summary of Research
GlaxoSmithKline is developing a new drug, (GSK3882347), for the treatment or prevention of uncomplicated Urinary Tract Infection (commonly referred to as UTI). This study drug is different from an antibiotic. It works by preventing the bacteria from attaching to the bladder and then causing an infection.
This is the first time this drug will be studied in humans. The main objective of this study is to understand the safety, tolerability and blood levels of GSK3882347 when given in single and multiple doses. It will also study the effect of food when taken with the drug.
The study will include 56 healthy participants, including males, and females who are unable to have children.
The study will consist of 2 parts; Part 1 and Part 2. Both parts will include a screening period of up to 30 days prior to the in-house treatment session, and a follow-up visit of approximately 14 days after the last dose.• Part 1:
16 participants in 2 groups of 8:
In each group, 6 participants will receive single doses of GSK3882347 and 2 will receive the placebo. Each group will have a minimum of 3 treatment periods. A fourth period will examine the effect of food on the drug’s activity in the body, and will be conducted in either group 1 or group 2, depending on the data seen from the previous treatment periods.• Part 2:
40 participants in 4 groups of 10.
Each participant will receive repeat (daily) doses of GSK3882347 or placebo for a single treatment period of 7 days.This study will have no direct medical benefit to volunteers. It is a GSK-sponsored study, and will be conducted in an MHRA-accredited clinical research unit in the United Kingdom, with appropriate safety and compliance facilities.
Summary of Results
GSK3882347 is being developed as an oral tablet for the treatment of urinary tract infections (UTI’s). Study 212148 was the first study which evaluated GSK332347 in humans.
In this two-part, phase 1 study eligible participants were healthy adults, aged 18–50 years. The primary aim of the study was to assess the safety and tolerability, of GSK3882347. The levels of the drug that got into the blood and urine when the patients were given different oral doses was also measured.
Twenty-one and 40 participants were randomised in Part 1 and Part 2 of the study, respectively. GSK3882347 was generally well tolerated when administered at single doses, or daily doses of 50–900 mg for 7 days, with no serious adverse events (i.e. unwanted or unexpected side-effects) or deaths on study.
The levels of drug in blood and urine were measured and were high enough to merit taking the drug forward for assessment in patient studies with UTI’s. These studies have recently started.REC name
HSC REC B
REC reference
20/NI/0083
Date of REC Opinion
20 Jul 2020
REC opinion
Further Information Favourable Opinion