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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01899105 |
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Date of registration:
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10/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
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Scientific 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 |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01899105 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: lumacaftor
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Drug: ivacaftor
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Primary Outcome(s)
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Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-8
[Time Frame: up to 5 days]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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VX13-809-012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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