HV Study of Oral Liquid Formulations of Budesonide (QSC200708)
Research type
Research Study
Full title
A Single Part, Four Period Sequential, Open Label Study Designed to Evaluate the In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in\nHealthy Subjects
IRAS ID
250259
Contact name
Philip Evans
Contact email
Sponsor organisation
Lek Pharmaceuticals
Eudract number
2018-003021-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The Sponsor is developing a thick oral liquid formulation (recipe) of the test medicine Budesonide, for the potential treatment of Eosinophilic oesophagitis (EoE). EoE is a condition where the oesophagus (the tube that connects the mouth to the stomach) becomes inflamed. \n \nThe test medicine budesonide is already marketed by another company for the treatment of EoE in the form of a tablet that dissolves on the tongue. The different thick oral liquid formulations of the test medicine to be tested in this study has been designed to deliver the medicine directly to the oesophagus. \n\nThe study will consist of 4 study periods involving up to 12 healthy male and female volunteers. During each period volunteers will receive a single dose of a different thick oral liquid formulation of the test medicine. Each formulation will be radiolabelled with technetium-99m (99mTc), which when taking images with a specialised camera, will allow us to track how the formulations travel down the oesophagus when swallowed. Imaging will be performed for 4 minutes after dosing and volunteers will remain in the clinical unit for 24 hours after each dose for safety assessments to be performed. \n\nThe safety and tolerability of the oral liquid formulation will also be assessed.\n
REC name
Wales REC 2
REC reference
18/WA/0338
Date of REC Opinion
17 Oct 2018
REC opinion
Further Information Favourable Opinion