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NCT01746784 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
A Phase 1 study, sponsored by Nivalis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT01746784: Completed Phase 1 study, sponsored by Nivalis Therapeutics.
NCT01746784 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01746784, a Phase 1 study, has completed, sponsored by Nivalis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation.
Primary Outcome
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Interventions
- DRUG Normal saline
- DRUG N6022
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01746784 record still lists
NCT01746784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT01746784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01746784 about?
NCT01746784 is a clinical study titled "Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation". The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation.
What is the current status of trial NCT01746784?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2014-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01746784?
The interventions under investigation include: Normal saline (DRUG), N6022 (DRUG).
Who is sponsoring clinical trial NCT01746784?
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 NCT01746784's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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