FDL169 and FDL176 Drug Drug Interaction Study (QCL118325)
Research type
Research Study
Full title
A Phase 1, Open label, Drug-Drug Interation Study of FDL169 and FDL176 in Healthy Subjects
IRAS ID
239705
Contact name
Jingwen Chai
Contact email
Sponsor organisation
Flatley Discovery Lab, LLC
Eudract number
2017-004867-11
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The Sponsor is developing the test medicines FDL169 and FDL167, for the potential treatment of Cystic Fibrosis. Cystic Fibrosis is a genetic condition (a condition that someone 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 purpose of this study is to see how well FD176 is taken up by the body when given with FD169. This is because the sponsor is aiming to develop a combination medicine for the treatment of Cystic Fibrosis containing both FD176 and FD169.
This is a 2 part study. In Part 1, 16 healthy volunteers will receive single doses of FDL176 with and without FD169, in the fed state (with food). In Part 2, an additional 16 healthy volunteers will receive multiple doses of FDL176 with and without FD169, in the fed state (with food). For Part 1, volunteers will be resident in the clinical unit from Day -1 to Day 3 followed by daily outpatients visits until Day 6. Volunteers will then be readmitted on the morning of Day 7 and remain in the unit until Day 29. For Part 2, volunteer will be resident from Day -1 to Day 29.
Part 2 of the study will only go ahead once Part 1 has been completed.
REC name
Wales REC 2
REC reference
18/WA/0006
Date of REC Opinion
21 Feb 2018
REC opinion
Favourable Opinion