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