Vertex (VX11-661-101) Study

A Phase 2, multicenter, double-blinded, placebo-controlled study to evaluate safety,
efficacy, pharmacokinetics, and pharmacodynamics of VX-661 monotherapy and VX-661/VX-770 cotherapy in subjects with cystic fibrosis, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

VX-661 and VX-770 are two different but complementary drugs that may help correct some of the irregularities or deformities that the gene mutation causes. VX-661 and VX-770 are being studied together to see if they can help decrease some of the effects caused by CF. They are designed to help the mutated chloride channel work more effectively which could alleviate the cycle of mucus plugging, infection, and inflammation in the lungs caused by CF.

This is the first time VX-661 and VX-770 are being given together. This is also the first time that VX-661 will be given to subjects with CF. The study is being done to learn more about the safety and effects of VX-661 when given alone and in combination with VX-770 to subjects with CF. We will also look at how VX-661 and VX-770 may affect your body and how your body breaks down and eliminates the drugs.