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.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy)
• History of Gilbert's syndrome
• Pregnant or nursing female subjects
• Male subject who has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
• Blood donation of approximately 1 pint (500 mL) within 56 days before study drug administration
• Subjects who smoke (subjects who have stopped smoking at least 6 months before screening are considered nonsmokers)
• 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)