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NCT02227888 · ClinicalTrials.gov registry record · Phase 1
PK Study of N91115 in Cystic Fibrosis Patients
A Phase 1 study of Cystic Fibrosis, sponsored by Nivalis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 3
- Study locations
NCT02227888 is a Phase 1 study of Cystic Fibrosis that has completed, run by Nivalis Therapeutics. The registered enrollment target is 6 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT02227888, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Nivalis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 3
- Study locations
Study Summary
This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase 2 trials.
Conditions Studied
Interventions
- DRUG N91115
Study Locations (3)
Colorado
- Children's CO - Aurora
- National Jewish Health - Denver
Alabama
- University of Alabama @ Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02227888
The ClinicalTrials.gov registry entry for NCT02227888 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (97% lower). The listed sponsor is Nivalis Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which N91115 is the first listed.
NCT02227888 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT02227888 about?
NCT02227888 is a clinical study titled "PK Study of N91115 in Cystic Fibrosis Patients". This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase 2 trials.
What is the current status of trial NCT02227888?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-10. Estimated completion is 2015-01.
What conditions does trial NCT02227888 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02227888?
The interventions under investigation include: N91115 (DRUG).
Who is sponsoring clinical trial NCT02227888?
This trial is sponsored by Nivalis Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02227888 being conducted?
This trial has 3 study locations across Alabama, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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