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

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ClinicalTrials.gov Identifier: NCT01899105
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: lumacaftor Drug: ivacaftor Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ivacaftor

Arm Intervention/treatment
Experimental: 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
Drug: lumacaftor
Other Name: VX-809

Drug: ivacaftor
Other Name: VX-770

Experimental: 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
Drug: lumacaftor
Other Name: VX-809

Drug: ivacaftor
Other Name: VX-770

Primary Outcome Measures :
  1. Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞ [ Time Frame: up to 5 days ]

Secondary Outcome Measures :
  1. Safety and tolerability as assessed by adverse events (AEs), laboratory assessments (serum chemistry and hematology), vital signs, standard 12-lead electrocardiograms (ECGs), and spirometry [ Time Frame: up to 25 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899105

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United States, Florida
Daytona, Florida, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01899105    
Other Study ID Numbers: VX13-809-012
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action