Vertex 661 (Tezacaftor) Study (Phase 2)
Study ID number: VX11-661-101
Official Title: A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
VX-661 (Tezacaftor) and VX-770 (Ivacaftor) 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 was the first time VX-661 and VX-770 are being given together. This was the first time that VX-661 was given to subjects with CF. The study was 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. VX-661 and VX-770 were investigated in how they may affect your body and how your body breaks down and eliminates the drugs.
The study was completed and was approved to move into Phase 3.
Source: ClinicalTrials. gov: https://clinicaltrials.gov/ct2/show/NCT01531673
Press releases related to the study: