Pharmacokinetic Study of FDL169 in Healthy Subjects (QCL118112)
Research type
Research Study
Full title
A Phase 1, Open-label, Randomised, Cross-over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses
IRAS ID
237847
Contact name
Claudia Ordonez
Contact email
Sponsor organisation
Flatley Discovery Lab, LLC
Eudract number
2017-004586-27
Duration of Study in the UK
0 years, 3 months, 7 days
Research summary
Flatley Discovery Lab (the sponsor) is developing a new test medicine (FDL169) for the treatment of Cystic Fibrosis. Cystic Fibrosis is a genetic condition (a condition which the patient is born with) in which the lungs and digestive system can become clogged with thick, sticky mucus. There is currently no cure for Cystic Fibrosis and the average life expectancy for Cystic Fibrosis patients who live to adulthood is 41 years.
The study will aim to compare the amount of test medicine that is taken up by the body and to measure the amount of break down products following dosing of 3 different tablet formulations (recipes). The safety and tolerability of the test medicine will also be assessed, as will the effect of food on dosing.
The study will consist of up to 6 study periods involving up to 12 healthy male and female volunteers who are non-pregnant or not breastfeeding. Each volunteer will receive a single dose of the test medicine each period. Volunteers will then remain in the clinical unit for 48 hours for blood samples to be taken and safety assessments performed.
REC name
Wales REC 2
REC reference
18/WA/0010
Date of REC Opinion
24 Jan 2018
REC opinion
Favourable Opinion