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

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: lumacaftor; Drug: ivacaftor

• Registration Number: NCT01899105
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A	lumacaftor	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
Part A	ivacaftor	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
Part B	lumacaftor	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
Part B	ivacaftor	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞	up to 5 days

Secondary Outcome Measures

Name	Time	Method
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