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NCT04069689 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.
A Phase 1 study, sponsored by Epygenix.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04069689: Completed Phase 1 study, sponsored by Epygenix.
NCT04069689 is a Phase 1 study that has completed, run by Epygenix. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04069689, a Phase 1 study, has completed, sponsored by Epygenix.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. The safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 will be assessed in fasting healthy subjects and following a high-fat meal.
Primary Outcome
To evaluate the safety of single and multiple escalating doses of oral EPX-100 in healthy subjects.
Interventions
- DRUG Placebos
- DRUG EPX-100 (Clemizole Hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2019-11-27 |
| Phase | Phase 1 |
What the finished NCT04069689 record still lists
NCT04069689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04069689 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04069689 about?
NCT04069689 is a clinical study titled "Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.". This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. The safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 will be assessed in fasting healthy subjects and following a high-fat meal.
What is the current status of trial NCT04069689?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-08-29. Estimated completion is 2019-11-27.
What interventions are being tested in trial NCT04069689?
The interventions under investigation include: Placebos (DRUG), EPX-100 (Clemizole Hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT04069689?
This trial is sponsored by Epygenix, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04069689's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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