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
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Homozygous for the F508del-CFTR mutation; historical genotype must be documented in the participant's source documents.
Percent predicted FEV1 \<40 of adjusted for age, sex, and height at Screening
You may not be if
Participant currently receiving invasive mechanical ventilation.
History of any comorbidity 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
Any clinically significant laboratory abnormalities at screening that would interfere with the study assessments or pose an undue risk for the subject
A 12-lead electrocardiograms (ECG) demonstrating QTcF \>450 msec at Screening
History of solid organ or hematological transplantation
History of alcohol or drug abuse in the past year
Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening.
Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A
Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.
Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
Use of beta blockers or the equivalent at Screening.
Clareo Health | Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
