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A Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users

NCT03200080 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-08-13

No results posted yet for this study

Summary

This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational polydrug users with stimulant experience, under fed conditions.

Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.

Conditions

  • Abuse Potential

Interventions

DRUG

Tozadenant

2, 4, 6 or 8 Tozadenant 60 mg tablets

DRUG

Placebo oral tablet

2, 4, 6 or 8 Tozadenant matching placebo tablets

DRUG

d-amphetamine

2 or 4 capsules, each containing 2 over-encapsulated d-amphetamine 5 mg tablets

DRUG

Placebo oral capsule

2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet

Sponsors & Collaborators

  • Acorda Therapeutics

    collaborator INDUSTRY

  • Biotie Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Michael McDonnell, MD · INC Research Toronto

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2017-11-28
Completion
2017-11-28
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200080 on ClinicalTrials.gov