Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
With
Cystic Fibrosis Foundation
Age
2–5
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female with confirmed diagnosis of CF
Must have a CFTR gating mutation in at least 1 allele
Aged 2 through 5 years at screening and Day 1
Weight \>= 8 kg at screening and Day 1
Hematology, serum chemistry, coagulation, and vital signs results at screening with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator
You may not be if
History of any illness or condition 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, or pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks before Day 1
Abnormal liver function, at screening
History of solid organ or hematological transplantation
Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1
Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives before screening
Clareo Health | Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
