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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 is a Phase 1 study that has completed, run by Embera NeuroTherapeutics. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02406066
The ClinicalTrials.gov registry entry for NCT02406066 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Embera NeuroTherapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02406066 reports 0 study locations.
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.
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