Healthy Volunteers Clinical Trial
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).
Subjects will be randomized to 1 of 10 treatment sequences according to a two 5 x 5 William
squares design. To maintain blinding, subjects will be required to ingest eight capsules
with approximately 240 mL water on each study drug administration day.
Serial pharmacodynamic (PD) evaluations will be conducted up to 24 hours after each study
drug administration. Pharmacokinetic (PK) samples will be obtained to confirm exposure to
EB-1020. Safety monitoring will include recording of adverse events (AEs), regular
assessments of vital signs measurements, 12-lead electrocardiogram (ECG) findings, and
continuous telemetry monitoring for at least 3 hours after study drug administration.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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