Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
Public ClinicalTrials.gov record NCT00457821. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
Study identification
- NCT ID
- NCT00457821
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 39 participants
Conditions and interventions
Conditions
Interventions
- Ivacaftor 25 mg/75 mg Drug
- Ivacaftor 75 mg/150 mg Drug
- Ivacaftor 150 mg or 250 mg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2007 (Type not available)
- Primary completion
- Aug 2008 (Actual)
- Completion
- Aug 2008 (Actual)
- Last update posted
- Oct 5, 2012
2007 – 2008
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Hospital | Birmingham | Alabama | 35211 | — |
| Stanford University Medical Center | Palo Alto | California | 34304 | — |
| The Children's Hospital | Aurora | Colorado | 80045 | — |
| Roy J. and Lucille A. Carver College of Medicine, The University of Iowa | Iowa City | Iowa | 52242-1083 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Pulmonary and Critical Care Medicine, Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Children's Hospital of Boston | Boston | Massachusetts | 02215 | — |
| Division of Pulmonary, Allergy and Critical Care Medicine, University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Cystic Fibrosis Pulmonary Research and Treatment Center, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4399 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Pulmonary Critical Care, University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00457821, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2012 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00457821 live on ClinicalTrials.gov.