A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
Information source: Euthymics BioScience, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers; Drug Users
Intervention: EB-1020 400 mg (Drug); EB-1020 800 mg (Drug); lisdexamfetamine 150 mg (Drug); d-amphetamine 40 mg (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Neurovance, Inc.
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).
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
Secondary outcome: Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])Overall Drug Liking VAS (Emax/Emin) Take Drug Again VAS (Emax) High VAS (Emax and TA_AUE) Good Effects VAS (Emax and TA_AUE) Bad Effects VAS (Emax and TA_AUE) Nausea VAS (Emax and TA_AUE) ARCI-A scale (Emax and TA_AUE) ARCI-BG scale (Emax and TA_AUE) Alertness/Drowsiness VAS (Emax and TA_AUE) Agitation/Relaxation VAS (Emax and TA_AUE) Any Effects VAS (Emax and TA_AUE) Drug Similarity VAS (score at 12 hours after study drug administration) Safety and tolerability of EB-1020 as assessed by AEs Safety and tolerability of EB-1020 by laboratory assessments Safety and tolerability of EB-1020 as assessed by 12-lead ECGs Safety and tolerability of EB-1020 as assessed by vital signs
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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.
Locations and Contacts
Vince and Associates Clinical Research, Inc., Overland Park, Kansas 66212, United States
Additional Information
Starting date: May 2014
Last updated: August 13, 2014
|