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NCT03712163 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
A Phase 1 study, sponsored by Emergo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT03712163: Completed Phase 1 study, sponsored by Emergo Therapeutics.
NCT03712163 is a Phase 1 study that has completed, run by Emergo Therapeutics. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03712163, a Phase 1 study, has completed, sponsored by Emergo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.
Primary Outcome
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
Interventions
- DRUG Placebo Oral Capsule
- DRUG Norketotifen Oral Capsule (Cohort 1)
- DRUG Norketotifen Oral Capsule (Cohort 2)
- DRUG Norketotifen Oral Capsule (Cohort 3)
- DRUG Norketotifen Oral Capsule (Multiple Dose Cohort)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2019-03-14 |
| Phase | Phase 1 |
What the finished NCT03712163 record still lists
NCT03712163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo Oral Capsule is the first listed.
NCT03712163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03712163 about?
NCT03712163 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects". This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.
What is the current status of trial NCT03712163?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2018-10-15. Estimated completion is 2019-03-14.
What interventions are being tested in trial NCT03712163?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Norketotifen Oral Capsule (Cohort 1) (DRUG), Norketotifen Oral Capsule (Cohort 2) (DRUG), Norketotifen Oral Capsule (Cohort 3) (DRUG), Norketotifen Oral Capsule (Multiple Dose Cohort) (DRUG).
Who is sponsoring clinical trial NCT03712163?
This trial is sponsored by Emergo Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03712163's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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