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

Condition(s) targeted: Healthy Volunteer

Intervention: RO4917838 (Drug); diazepam (Drug); Placebo (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Please reference Study ID Number: BP25259, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

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.

Official title: Human Abuse Liability Study in Recreational Drug Users to Investigate the Abuse Liability Potential of RO4917838

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS)

Secondary outcome:

Safety: Incidence of adverse events

Pharmacokinetics: plasma concentrations of RO4917838

Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female volunteers, 18 to 55 years of age inclusive

- Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS depressant,

>/= 1 abuse of CNS depressant in the previous 3 months

- Body mass index (BMI) 18 to 30 kg/m2 inclusive

- Main study (Part 2): Able to differentiate between diazepam and placebo

Exclusion Criteria:

- History of any significant disease or disorder

- History or current diagnosis of substance dependence (excluding caffeine and

nicotine)

- Currently seeking or history of participating in treatment for substance-related

disorders, including successful completion of such treatment

- Any confirmed significant allergic reactions against any drug, or multiple allergies

in the judgement of the investigator

- Positive for hepatitis B, hepatitis C or HIV infection

- Pregnant or lactating women

- Participation in an investigational drug or device study within the last 30 days

prior to Day 1 of the study

- Confirmed positive drug screening at screening / any Day -1 (allowed positive THC at

screening and any Day - 1 and positive benzodiazepine at screening only)

- Positive alcohol breath test at screening / any Day -1

- Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)

Please reference Study ID Number: BP25259, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

Salt Lake City, Utah 84106, United States

Starting date: November 2011
Last updated: December 5, 2011