A study to evaluate the effect of itraconazole on the PK of GSK3923868 in healthy participants
Research type
Research Study
Full title
A single centre, open label, single sequence study to evaluate the effect of itraconazole on the pharmacokinetics of single inhaled doses of GSK3923868 in healthy participants.
IRAS ID
1007593
Contact name
Alex West
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
GSK is developing a new drug GSK3923868 (study drug) for the treatment of infections caused by Human Rhinoviruses (HRV). Rhinoviruses mostly cause infections of the nose, throat and chest. They are the most common cause of the common cold. The most typical symptoms of the common cold include a blocked or runny nose, sore throat, cough, headache and muscle aches.
Generally, most people will recover in 1 to 2 weeks. However, for those with long-term breathing conditions, such as Chronic Obstructive Pulmonary Disease (COPD), the HRV infection can lead to a sudden worsening of disease symptoms (exacerbations) if the lung is infected. Currently there are no available treatments for HRV infections. The study drug is a new inhaled medicine that is delivered to the lung using an inhaler device called ELLIPTA. Once in the lung, the study drug works to stop the virus reproducing itself, which may support the body’s ability to fight the infection and reduce injury to the lung.
The purpose of this study is to understand whether the body breaks down GSK3923868 differently before and after itraconazole treatment. Itraconazole is an approved medicine used to treat fungal infections. The reason itraconazole is used is to see if it alters GSK3923868 levels in the blood. The results from this study will help us understand how other medications commonly used to treat patients with COPD could also affect levels of GSK3923868 (for example, antibiotics to treat infections).
Approximately twenty males and females that can no longer bear children, aged between 18 and 65 years will be enrolled in the study to ensure that at least 16 participants complete the study. The study treatment will be administered to participants within 2 dosing periods in total. The study will take place at the GSK clinical unit in Cambridge, where subjects’ safety and wellbeing will be monitored.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0564
Date of REC Opinion
27 Aug 2024
REC opinion
Further Information Favourable Opinion