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A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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).
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2014-05-01
Completion Date
2014-07-01
Last Updated
2026-04-13
Healthy Volunteers
Yes
Conditions
Interventions
EB-1020 400 mg
4 x EB-1020 100-mg capsules, and 4 matching placebo capsules
EB-1020 800 mg
8 x EB-1020 100-mg capsules
lisdexamfetamine 150 mg
3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules
d-amphetamine 40 mg
4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules
Placebo
8 x matching placebo capsules
Locations (1)
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States