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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 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 66 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01746784
The ClinicalTrials.gov registry entry for NCT01746784 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nivalis Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT01746784 reports 0 study locations.
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.
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