Full title

A Phase 2 study of 2 CFTR modulators (FDL169 & FDL176) in people with cystic fibrosis 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

125691

Trial type

Medication

Intervention

FDL169 and FDL176

Last edited date

06 December 2019

CF sponsor

Flatley Discovery Lab LLC

CF sponsor type

Commercial