A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
brief 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).
detailed description
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.