Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation
Public ClinicalTrials.gov record NCT02275936. 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 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.
Study identification
- NCT ID
- NCT02275936
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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 2015 (Type not available)
- Primary completion
- Jul 2015 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Nov 7, 2016
2015
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama @ Birmingham | Birmingham | Alabama | 35294 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Children's CO | Aurora | Colorado | 80045 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Columbia University | New York | New York | 10032 | — |
| The New York Presbyterian Hospital, Columbia University Medical Center | New York | New York | 10032 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Children's Hospital - Case Medical Center | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02275936, 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 Nov 7, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02275936 live on ClinicalTrials.gov.