the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
Restore CFTR Function
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation
In this study investigational CFTR modulators called FDL169 and FDL176 will be studied when given in combination. FDL169 is an oral medication that improves the function of the protein that is defective in Cystic Fibrosis (the CFTR protein), a type of compound known as a CFTR corrector.
FDL169 is planned as a long-term treatment of CF in people who have the genetic mutation known as F508del-CFTR mutation. FDL176 is an oral medication that aims to improve the function of the protein that is defective in Cystic Fibrosis (CF) (the CFTR protein), a type of compound known as a CFTR potentiator.
The aim of this trial is to study how well FDL169 and FDL176 are tolerated by people with CF when given in combination. In addition, the trial will study how the medications move around the body, and how they are absorbed and digested. For this purpose, the amount of FDL169 and FDL176 will be measured in your blood at specific intervals after you take the tablet orally (this is called pharmacokinetics [PK]). The impact on your CF will also be measured with tests for sweat chloride and changes in lung volumes, measured by spirometry tests.
Trial Reference Number
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the name of the treatment or therapy being researched
FDL169 and FDL176
Last edited date
29 October 2019
Flatley Discovery Lab LLC
CF sponsor type