Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.

Key facts

Study ID

NCT01531673

Run by

Vertex Pharmaceuticals Incorporated

People needed

194

Starts

2012-02-01

Expected to finish

2014-03-01

Last updated by the study team

2018-04-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female with confirmed diagnosis of CF
• Must have the F508del-CFTR gene mutation in both alleles (Groups 1, 2, 3, 4, 5, 6). Group 7 participants must have the F508del-CFTR mutation on 1 allele, and gating mutation G551D on the second allele and have been on their physician prescribed 150 mg KalydecoTM q12h (commercially available ivacaftor) for at least 28 days at the Screening Visit.
• Forced expiratory volume in 1 second(FEV1) 40% to 90% (inclusive) of predicted normal for age, gender, and height (Knudson standards) at screening
• Weight >40 kg and BMI >18.5
• Participants of child-bearing potential and who are sexually active must meet the contraception requirements.

You may not qualify if…

• History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant.
• An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Study Day 1.
• History of solid organ or hematological transplantation
• Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer) before screening
• History of alcohol, medication, or illicit drug abuse within 1 year prior to screening
• Pregnant, breast-feeding, or not willing to follow contraception requirements

Where it is running

• Vertex Investigational Site — Birmingham, Alabama, United States
• Vertex Investigational Site — Oakland, California, United States
• Vertex Investigational Site — Boise, Idaho, United States
• Vertex Investigational Site — Chicago, Illinois, United States
• Vertex Investigational Site — Boston, Massachusetts, United States
• Vertex Investigational Site — Grand Rapids, Michigan, United States
• Vertex Investigational Site — Kansas City, Missouri, United States
• Vertex Investigational Site — Long Branch, New Jersey, United States
• Vertex Investigational Site — New Hyde Park, New York, United States
• Vertex Investigational Site — Chapel Hill, North Carolina, United States
• Vertex Investigational Site — Cincinnati, Ohio, United States
• Vertex Investigational Site — Columbus, Ohio, United States
• Vertex Investigational Site — Oklahoma City, Oklahoma, United States
• Vertex Investigational Site — Hershey, Pennsylvania, United States
• Vertex Investigational Site — Pittsburgh, Pennsylvania, United States
• Vertex Investigational Site — Charleston, South Carolina, United States
• Vertex Investigational Site — Salt Lake City, Utah, United States
• Vertex Investigational Site — Burlington, Vermont, United States
• Vertex Investigational Site — Seattle, Washington, United States
• Vertex Investigational Site — Calgary, Alberta, Canada
• Vertex Investigational Site — Vancouver, British Columbia, Canada
• Vertex Investigational Site — Halifax, Nova Scotia, Canada
• Vertex Investigational Site — Toronto, Ontario, Canada
• Vertex Investigational Site — Erlangen, Bavaria, Germany
• Vertex Investigational Site — Frankfurt am Main, Hesse, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.