A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.

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

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Be in good general physical health

• Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg

• Recreational opioid use experience for non-therapeutic purposes (at >/= 10 times in lifetime and >/= 1 in previous 3 months

• Agree to use an approved method of birth control for the duration of the study

• Additional criteria may apply

Exclusion Criteria:

• Currently pregnant or breastfeeding

• History of or current infection with hepatitis B virus, hepatitis C virus or HIV

• Current or history of any clinically significant medical or psychiatric condition

• Current or history of in the last 2 years of dependence on alcohol or any illicit drugs

• Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days

• Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)

• Additional criteria may apply