A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation

Inclusion Criteria: * Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF). * Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. * Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation * Forced Expiratory Volume in one second/forced vital capacity (FEV1) ≥40% of predicted normal for age, sex, and height Exclusion Criteria: * Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C) * Subjects currently receiving invasive mechanical ventilation * Known history of alcohol or drug abuse in the past year * Clinically significant abnormal laboratory values during screening * Pregnant or nursing females * Female subjects and female partners of male subjects who plan to become pregnant during Treatment Period or within 90 days following the last dose of study drug * History of solid organ or hematological transplantation * Ongoing or prior participation in an investigational drug study within 30 days of screening * Current use of commercial LUM/IVA combination therapy