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NCT03404817 · ClinicalTrials.gov registry record · Phase 1
Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations
A Phase 1 study, sponsored by Embera NeuroTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03404817: Completed Phase 1 study, sponsored by Embera NeuroTherapeutics.
NCT03404817 is a Phase 1 study that has completed, run by Embera NeuroTherapeutics. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03404817, a Phase 1 study, has completed, sponsored by Embera NeuroTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences
Primary Outcome
The AUC0-inf is calculated in a plot of concentration of drug in blood plasma against time and extrapolated to infinity.
Interventions
- DRUG Original formulation EMB-001
- DRUG New formulation EMB-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2018-06-07 |
| Phase | Phase 1 |
What the finished NCT03404817 record still lists
NCT03404817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Original formulation EMB-001 is the first listed.
NCT03404817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03404817 about?
NCT03404817 is a clinical study titled "Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations". This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability a...
What is the current status of trial NCT03404817?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2018-03-01. Estimated completion is 2018-06-07.
What interventions are being tested in trial NCT03404817?
The interventions under investigation include: Original formulation EMB-001 (DRUG), New formulation EMB-001 (DRUG).
Who is sponsoring clinical trial NCT03404817?
This trial is sponsored by Embera NeuroTherapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03404817's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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