A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

Inclusion Criteria:

- Male and female subjects must be between the ages of 18 and 55 years, inclusive

- Body mass index (BMI) of 18 to 31 kg/m2, inclusive, and a total body weight >50 kg.

Exclusion Criteria:

- History of any illness that, in the opinion of the investigator, might confound the
results of the study or pose an additional risk in administering study drug(s) to the
subject. This may include, but is not limited to, a history of relevant drug or food
allergies; history of cardiovascular or central nervous system disease; history or
presence of clinically significant pathology; or history of mental disease.

- History of febrile illness within 5 days before the first dose.

- History of Gilbert's syndrome

- Abnormal renal function as defined at screening

- Blood donation of approximately 1 pint (500 mL) within 56 days before study drug
administration

- Treatment with an investigational drug within 30 days or 5 half-lives (or as
determined by the local requirements, whichever is longer) preceding the first dose
of study drug

- Known hypersensitivity or prior adverse reaction to ciprofloxacin, or any member of
the quinolone class of antimicrobial agents (Cohort 1 only); itraconazole, or to any
of the other azoles (Cohort 2 only); rifampin, or to any of the rifamycins (Cohort 3
only)