Status:
COMPLETED
Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosi...
Detailed Description
This was a double-blind, placebo-controlled, cross-over, multiple dose study of up to 28 days of dosing, in subjects with cystic fibrosis (CF) who have a G551D-CTFR gene mutation. Enrollment of 39 sub...
Eligibility Criteria
Inclusion
- Weighing at least 40 kg
- Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele
- Forced expiratory volume in 1 second (FEV1) of at least 40% of predicted normal for age, gender, and height
- Willing to remain on stable medication regimen for the duration of study participation
- No significant clinical laboratory abnormalities, not pregnant, and willing to use at least 2 highly effective birth control methods during Part 1 and 1 highly effective birth control method during Part 2 of the study
- No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator
Exclusion
- History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
- Ongoing acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 14 days of Day 1 of the study
- History of alcohol, medication or illicit drug abuse within one year prior to Day 1
- Abnormal liver function ≥ 3x the upper limit of normal
- History of abnormal renal function (creatinine clearance \< 50 mL/min using Cockcroft-Gault equation)
- History of solid organ or hematological transplantation
- Pregnant or breast-feeding (for women)
- Ongoing participation in another therapeutic clinical trial, or prior participation in an investigational drug study without appropriate washout
- Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP3A4)
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00457821
Start Date
May 1 2007
End Date
August 1 2008
Last Update
October 5 2012
Active Locations (15)
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1
University of Alabama Hospital
Birmingham, Alabama, United States, 35211
2
Stanford University Medical Center
Palo Alto, California, United States, 34304
3
The Children's Hospital
Aurora, Colorado, United States, 80045
4
Roy J. and Lucille A. Carver College of Medicine, The University of Iowa
Iowa City, Iowa, United States, 52242-1083