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NCT02275936 · ClinicalTrials.gov registry record · Phase 1
Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation
A Phase 1 study, sponsored by Nivalis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02275936: Completed Phase 1 study, sponsored by Nivalis Therapeutics.
NCT02275936 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02275936, a Phase 1 study, has completed, sponsored by Nivalis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG N91115
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT02275936 record still lists
NCT02275936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which N91115 is the first listed.
NCT02275936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02275936 about?
NCT02275936 is a clinical study titled "Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation". 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 th...
What is the current status of trial NCT02275936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2015-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02275936?
The interventions under investigation include: N91115 (DRUG).
Who is sponsoring clinical trial NCT02275936?
This trial is sponsored by Nivalis Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02275936's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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