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