Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation
Public ClinicalTrials.gov record NCT01531673. 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 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy 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 the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.
Study identification
- NCT ID
- NCT01531673
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 194 participants
Conditions and interventions
Conditions
Interventions
- VX-661 Drug
- Ivacaftor Drug
- Placebo matched to VX-661 Drug
- Placebo matched to ivacaftor Drug
Drug
Eligibility (public fields only)
- Age range
- 12 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
- Feb 2012 (Type not available)
- Primary completion
- Mar 2014 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Apr 13, 2018
2012 – 2014
United States locations
- U.S. sites
- 19
- U.S. states
- 17
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vertex Investigational Site | Birmingham | Alabama | — | — |
| Vertex Investigational Site | Oakland | California | — | — |
| Vertex Investigational Site | Boise | Idaho | — | — |
| Vertex Investigational Site | Chicago | Illinois | — | — |
| Vertex Investigational Site | Boston | Massachusetts | — | — |
| Vertex Investigational Site | Grand Rapids | Michigan | — | — |
| Vertex Investigational Site | Kansas City | Missouri | — | — |
| Vertex Investigational Site | Long Branch | New Jersey | — | — |
| Vertex Investigational Site | New Hyde Park | New York | — | — |
| Vertex Investigational Site | Chapel Hill | North Carolina | — | — |
| Vertex Investigational Site | Cincinnati | Ohio | — | — |
| Vertex Investigational Site | Columbus | Ohio | — | — |
| Vertex Investigational Site | Oklahoma City | Oklahoma | — | — |
| Vertex Investigational Site | Hershey | Pennsylvania | — | — |
| Vertex Investigational Site | Pittsburgh | Pennsylvania | — | — |
| Vertex Investigational Site | Charleston | South Carolina | — | — |
| Vertex Investigational Site | Salt Lake City | Utah | — | — |
| Vertex Investigational Site | Burlington | Vermont | — | — |
| Vertex Investigational Site | Seattle | Washington | — | — |
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 NCT01531673, 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 Apr 13, 2018 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01531673 live on ClinicalTrials.gov.