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

NCT ID: NCT02144415

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-07-31

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.

Conditions

Healthy Volunteers; Drug Users

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EB-1020 400 mg

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

Group Type: EXPERIMENTAL

EB-1020 400 mg

Intervention Type: DRUG

4 x EB-1020 100-mg capsules, and 4 matching placebo capsules

EB-1020 800 mg

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

Group Type: EXPERIMENTAL

EB-1020 800 mg

Intervention Type: DRUG

8 x EB-1020 100-mg capsules

lisdexamfetamine 150 mg

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

Group Type: ACTIVE_COMPARATOR

lisdexamfetamine 150 mg

Intervention Type: DRUG

3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules

d-amphetamine 40 mg

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

Group Type: ACTIVE_COMPARATOR

d-amphetamine 40 mg

Intervention Type: DRUG

4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules

Placebo

Placebo, administered as 8 matching placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

8 x matching placebo capsules

Interventions

EB-1020 400 mg

4 x EB-1020 100-mg capsules, and 4 matching placebo capsules

Intervention Type: DRUG

EB-1020 800 mg

8 x EB-1020 100-mg capsules

Intervention Type: DRUG

lisdexamfetamine 150 mg

3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules

Intervention Type: DRUG

d-amphetamine 40 mg

4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules

Intervention Type: DRUG

Placebo

8 x matching placebo capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Neurovance, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

EB-1020 IR-103

Identifier Type: -

Identifier Source: org_study_id