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NCT02013388 · ClinicalTrials.gov registry record · Phase 1
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
A Phase 1 study, sponsored by Nivalis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02013388: Completed Phase 1 study, sponsored by Nivalis Therapeutics.
NCT02013388 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013388, a Phase 1 study, has completed, sponsored by Nivalis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
Primary Outcome
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Interventions
- DRUG Placebo
- DRUG N91115
- DRUG Placebo-Day 1 only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT02013388 record still lists
NCT02013388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02013388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02013388 about?
NCT02013388 is a clinical study titled "MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects". A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
What is the current status of trial NCT02013388?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2014-02. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02013388?
The interventions under investigation include: Placebo (DRUG), N91115 (DRUG), Placebo-Day 1 only (DRUG).
Who is sponsoring clinical trial NCT02013388?
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 NCT02013388's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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