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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: Completed Phase 1 study of Cystic Fibrosis, sponsored by Nivalis Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the pharmacokinetics of N91115 after twice daily (q 12 h) doses given for 14 days by measuring plasma and urine concentrations of N91115 and its primary metabolite.
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 |
What the finished NCT02227888 record still lists
NCT02227888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02227888's enrollment target sits among peer trials
6 168th of 169 higher than 1 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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