NCT02144415

A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Drug Users

Interventions

Type	Name	Description
DRUG	EB-1020 400 mg	4 x EB-1020 100-mg capsules, and 4 matching placebo capsules
DRUG	EB-1020 800 mg	8 x EB-1020 100-mg capsules
DRUG	lisdexamfetamine 150 mg	3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules
DRUG	d-amphetamine 40 mg	4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules
DRUG	Placebo	8 x matching placebo capsules

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-05-22
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States