drugset / Trial / NCT01438749

A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users

NCT01438749

Phase 1 Completed 177 enrolled Hoffmann-La Roche
CrossoverDouble-blind

Summary

This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.

Timeline

Start
2011-10
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diazepam Small molecule
Subject bitopertin Small molecule Oral

Indications

No indication recorded.