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

• Status: Terminated
• Trial end date: 2017-11-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biotie Therapies Inc.
• Collaborator: Acorda Therapeutics
• Treatments: Amphetamine; Dextroamphetamine

Criteria

Inclusion Criteria:

• Healthy male or female subjects 18 to 55 years of age, inclusive.

• Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 and a minimum weight of at least 50.0 kg

• Current recreational polydrug users who self-report to:

• Have used stimulants (e.g., amphetamines, cocaine, methylphenidate) for non-therapeutic purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least 1 time in the 8 weeks before Screening.

• Have at least 10 lifetime uses of drugs (e.g., opioids, sedatives) from at least 1 other class other than alcohol.

• Agree to use an approved method of contraception

• Be willing and able to abide by all study requirements and restrictions

• Additional criteria may apply

Exclusion Criteria:

• Substance or alcohol dependence within the past 2 years,

• Clinically significant medical history or illness

• Female subjects who have a positive pregnancy test, are currently pregnant or lactating, or who are planning to become pregnant within 30 days of last study drug administration.

• Donation or loss of more than 500 mL whole blood within 30 days preceding the Screening visit.

• Additional criteria may apply.