['cystic fibrosis']
['lum/iva']

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      