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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: lumacaftor
* Drug: ivacaftor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>A single dose of 2 fixed-dose combination tablets of 200mg lumacaftor/125mg ivacaftor (total of 400mg lumacaftor/250mg ivacaftor) in the fed state and fasted state with a 14 day washout period in between each dosing occasion | Drug: lumacaftor<br> <br> * Other names: VX-809;Drug: ivacaftor<br> <br> * Other names: VX-770;|
| Experimental: Part B<br>A single dose of 3 fixed-dose combination tablets of 200mg lumacaftor/83mg ivacaftor (total of 600mg lumacaftor and 250mg ivacaftor) in the fed with a 14 day washout period in between dosing occasions | Drug: lumacaftor<br> <br> * Other names: VX-809;Drug: ivacaftor<br> <br> * Other names: VX-770;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞ |  | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by adverse events (AEs), laboratory assessments (serum chemistry and hematology), vital signs, standard 12-lead electrocardiograms (ECGs), and spirometry |  | up to 25 days |