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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |