Status:
COMPLETED
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male and female subjects as defined in the protocol
- Subjects who weigh \>50 kg at Screening
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01899105
Start Date
July 1 2013
End Date
August 1 2013
Last Update
April 3 2014
Active Locations (1)
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1
Daytona Beach, Florida, United States