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NCT02406066 · ClinicalTrials.gov registry record · Phase 1
Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001)
A Phase 1 study, sponsored by Embera NeuroTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02406066: Completed Phase 1 study, sponsored by Embera NeuroTherapeutics.
NCT02406066 is a Phase 1 study that has completed, run by Embera NeuroTherapeutics. 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
NCT02406066, a Phase 1 study, has completed, sponsored by Embera NeuroTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8 subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo. Neither the subjects nor the study personnel will know who got drug and who got placebo (double-blind). In the first group the drug doses will be low, and they will be increased in the second and third groups. Subjects will receive a single dose on Day 1, followed 24 hours later by the start of doses twice daily for 7 days, and then a final morning dose on the last day. The levels of the drugs in the blood will be assessed by repeated blood draws after the first day and after the end of dosing. Safety will be assessed after the single dose and repeated dosing. Effects of study drug on smoking and craving cigarettes will be assessed at the end of repeated dosing. The hypothesis is that this drug combination will be safe, with relatively few side effects.
Primary Outcome
Safety will be assessed through monitoring of adverse events (AE), physical examinations, vital signs, 12-lead ECG, Sheehan Suicidality Tracking Scale (S STS) and laboratory tests.
Interventions
- DRUG Placebo
- DRUG metyrapone & oxazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02406066 record still lists
NCT02406066 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 Placebo is the first listed.
NCT02406066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02406066 about?
NCT02406066 is a clinical study titled "Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001)". This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8 subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo. Neither the subjects nor ...
What is the current status of trial NCT02406066?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02406066?
The interventions under investigation include: Placebo (DRUG), metyrapone & oxazepam (DRUG).
Who is sponsoring clinical trial NCT02406066?
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 NCT02406066'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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