Status:
COMPLETED
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
Lead Sponsor:
Alkermes, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT02218021
Start Date
August 1 2014
End Date
November 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Alkermes Investigational Site
Overland Park, Kansas, United States, 66212