Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
2–5
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects who weigh ≥8 kilogram (kg) without shoes and wearing light clothing at the Screening Visit
Subjects with confirmed diagnosis of CF at the Screening Visit
Subjects who are homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation
You may not be if
Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
A standard 12-lead ECG demonstrating QTc \>450 millisecond (msec) at the Screening Visit.
History of solid organ or hematological transplantation.
Ongoing or prior participation in an investigational drug study (including studies investigating LUM and/or IVA) within 30 days of the Screening Visit.
History of cataract/lens opacity or evidence of cataract/lens opacity determined to be clinically significant by a licensed ophthalmologist during the ophthalmologic examination at the Screening Visit
Clareo Health | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
