Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
Public ClinicalTrials.gov record NCT01225211. 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 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
Study identification
- NCT ID
- NCT01225211
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 312 participants
Conditions and interventions
Conditions
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
- Oct 2010 (Type not available)
- Primary completion
- Apr 2014 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Oct 5, 2015
2010 – 2014
United States locations
- U.S. sites
- 38
- U.S. states
- 26
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Anchorage | Alaska | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | New Haven | Connecticut | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Iowa City | Iowa | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | New Hyde Park | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Sioux Falls | South Dakota | — | — |
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 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01225211, 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, 2015 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01225211 live on ClinicalTrials.gov.