PK of Sublingual Formuations of FLD169 (QCL117615)
Research type
Research Study
Full title
A Phase 1, Open-label, Cross-over, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects
IRAS ID
230383
Contact name
Claudia Ordonez
Contact email
Sponsor organisation
Flatley Discovery Lab, LLC
Eudract number
2017-002497-40
Duration of Study in the UK
0 years, 1 months, 18 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 patients are born with) in which the lungs and digestive system can become clogged with thick, sticky mucus. A faulty gene is inherited from both parents resulting in a faulty protein which affects the movement of salt and water in and out of cells. This, along with recurrent infections, can result in a build-up of thick, sticky mucus in the body's tubes and passageways.
The new test medicine, along with two other marketed treatments, work to restore the function of this faulty protein.
In previous clinical trials where FDL169 has been dosed as a tablet or a capsule formulation (recipe), both formulations were not taken up into the body well enough to have the desired effect. Therefore the aim of this study is to investigate administering FDL169 under the tongue (sublingually) in order to avoid it being broken down during digestion (first pass metabolism) and increase the amount being taken up into the bloodstream.
The study will compare how well the test medicine is taken up by the body when given orally (by mouth) and sublingually (under the tongue).
The safety and tolerability of the test medicine will also be assessed.
The study will consist of up to 2 parts. In Part 1, 12 healthy male and female volunteers who are non-pregnant or not breastfeeding will receive 20 mg of test medicine on two separate occasions, once swallowed and once sublingually (under the tongue). In optional Part 2, a further 12 subjects may receive the test medicine in the fed state on up to two separate occasions, as either the same formulation in Part 1 (at a different dose) or an optimised formulation once swallowed and/or once sublingually (under the tongue).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0409
Date of REC Opinion
7 Sep 2017
REC opinion
Further Information Favourable Opinion