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NCT02144415 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT02144415 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 80 participants.
The verdict
NCT02144415, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. The abuse potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety Follow-up visit (Visit 4).
Interventions
- DRUG Placebo
- DRUG EB-1020 400 mg
- DRUG EB-1020 800 mg
- DRUG lisdexamfetamine 150 mg
- DRUG d-amphetamine 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-05-01 |
| Est. Completion | 2014-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02144415
The ClinicalTrials.gov registry entry for NCT02144415 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02144415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02144415 about?
NCT02144415 is a clinical study titled "A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users". This single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. The abuse potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40...
What is the current status of trial NCT02144415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2014-05-01. Estimated completion is 2014-07-01.
What interventions are being tested in trial NCT02144415?
The interventions under investigation include: Placebo (DRUG), EB-1020 400 mg (DRUG), EB-1020 800 mg (DRUG), lisdexamfetamine 150 mg (DRUG), d-amphetamine 40 mg (DRUG).
Who is sponsoring clinical trial NCT02144415?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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