A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects

This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.

Inclusion Criteria:

• Healthy male and female subjects as defined in the protocol
• Subjects who weigh >50 kg at Screening

Exclusion Criteria:

• History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV
• Standard 12-lead ECG demonstrating QTc >450 msec for male subjects and >480 msec for female subjects at the Screening Visit
• Abnormal renal function as defined in the protocol at Screening
• Forced expiratory volume in 1 second (FEV1) <80% predicted at the Screening Visit
• Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug
• Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug