213252 Drug interaction assessment of GSK3882347 in Healthy Participants aged 18 to 65 years.
Research type
Research Study
Full title
A Phase 1, Open-Label study in Healthy Participants aged 18 to 65 years to Investigate the CYP3A4 Induction Potential of GSK3882347.
IRAS ID
1006579
Contact name
Ruth Mininger
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2022-002537-33
ISRCTN Number
ISRCTN16147016
Research summary
This research study will test a new GlaxoSmithKline (GSK) drug (GSK3882347) . A second drug will also be used in this study, called Midazolam, is a medicine approved by the national health agency in your country and is used to help with anxiety and relaxation before surgical procedures. This is an open label study which means volunteers will know which treatment they are to receive.
The GSK drug (GSK3882347) tested in this study was made to potentially treat bladder infections, also known as acute cystitis or uncomplicated urinary tract infections. So far, the drug has been given to 51 individuals aged 18 to 65 years of age in clinical trials.
This research study is being completed to test if the GSK study drug (GSK3882347) is safe and well-tolerated, in the presence of other medicines such as Midazolam. The study will also be completed to gain more information on how the body processes both study drugs individually and when given together. This study will be completed in healthy females (who are not pregnant or breast feeding) and male adults who are 18 to 65 years of age.
Approximately 24 to 36 people will take part in this study. The study will last for approximately 7 weeks or approximately 9 weeks for females who are choosing hormonal contraception as a method of birth control.
The study will consist of screening (up to 28 days prior to study entry), a treatment phase and follow-up. In the treatment phase, volunteers will stay in the clinical unit overnight from Day -1 (day before the start of dosing) and for 16 nights in a row during the dosing period. The dosing period of the study will start on Day 1 (the day after screening visit on Day-1) and is split into a dosing period 1 and dosing period 2.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0296
Date of REC Opinion
15 Mar 2023
REC opinion
Further Information Favourable Opinion