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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-08-31

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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Part A

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

Group Type EXPERIMENTAL

lumacaftor

Intervention Type DRUG

ivacaftor

Intervention Type DRUG

Part B

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

Group Type EXPERIMENTAL

lumacaftor

Intervention Type DRUG

ivacaftor

Intervention Type DRUG

Interventions

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lumacaftor

Intervention Type DRUG

ivacaftor

Intervention Type DRUG

Other Intervention Names

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VX-809 VX-770

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes