drugset / Trial / NCT03200080

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

Phase 1 Terminated 26 enrolled Biotie Therapies Inc. Acorda Therapeutics · collab
RandomizedCrossoverTriple-blindOther

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.

Timeline

Start
2017-09-18
Primary completion
2017-11-28
Completion
2017-11-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dextroamphetamine Small molecule 20 mg Oral
Comparator Dextroamphetamine Small molecule 40 mg Oral
Subject Tozadenant Small molecule 120 mg Oral
Subject Tozadenant Small molecule 240 mg Oral
Subject Tozadenant Small molecule 480 mg Oral

Indications