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

Neurovance

Status and phase: Completed; Phase 1

Conditions: Drug Users; Healthy Volunteers

Treatments: Drug: lisdexamfetamine 150 mg; Drug: Placebo; Drug: d-amphetamine 40 mg; Drug: EB-1020 400 mg; Drug: EB-1020 800 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02144415

EB-1020 IR-103

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects must be healthy male nondependent recreational drug users
2. Subjects must be 18 to 55 years old, inclusive.
3. Subjects must have greater than or equal to 10 lifetime nontherapeutic experiences with central nervous system (CNS) stimulants (e.g., amphetamines, cocaine, methylphenidate), greater than or equal to 1 nontherapeutic use of prescription stimulants within the 12 months prior to Screening, and greater than or equal to 1 nontherapeutic use of a CNS stimulant within the 12 weeks prior to Screening.

Exclusion criteria

1. Subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason.
2. Subjects who do not pass Qualification Phase criteria to be eligible for the Treatment Phase.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 5 patient groups, including a placebo group

EB-1020 400 mg

Experimental group

Description:

EB-1020 400 mg, administered as four 100-mg IR capsules and 4 matching placebo capsules

Treatment:

Drug: EB-1020 400 mg

EB-1020 800 mg

Experimental group

Description:

EB-1020 800 mg, administered as eight 100-mg IR capsules

Treatment:

Drug: EB-1020 800 mg

lisdexamfetamine 150 mg

Active Comparator group

Description:

lisdexamfetamine 150 mg, administered as 3 capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 matching placebo capsules

Treatment:

Drug: lisdexamfetamine 150 mg

d-amphetamine 40 mg

Active Comparator group

Description:

d-amphetamine 40 mg, administered as 4 capsules, each containing two 5-mg d-amphetamine tablets and 4 matching placebo capsules

Treatment:

Drug: d-amphetamine 40 mg

Placebo

Placebo Comparator group

Description:

Placebo, administered as 8 matching placebo capsules

Treatment:

Drug: Placebo