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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Samidorphan; Drug: Placebo; Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02218021

ALK33-012

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

59 participants in 6 patient groups, including a placebo group

Samidorphan Dose 1

Experimental group

Treatment:

Drug: Samidorphan

Samidorphan Dose 2

Experimental group

Treatment:

Drug: Samidorphan

Samidorphan Dose 3

Experimental group

Treatment:

Drug: Samidorphan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Oxycodone Dose 1

Active Comparator group

Treatment:

Drug: Oxycodone

Oxycodone Dose 2

Active Comparator group

Treatment:

Drug: Oxycodone