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

NCT02218021 | Completed Phase 1

• 1 other identifier: ALK33-012
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Alkermes; ALKS 33; ALKS 5461; Samidorphan

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)

  Approximately 4 weeks

Secondary Outcomes (2)

• Safety: Incidence of adverse events (AEs)

  Approximately 5.5 weeks

• Pharmacokinetics: Plasma concentrations of samidorphan and metabolite

  Approximately 4 weeks

Study Arms (6)

Samidorphan Dose 1

EXPERIMENTAL

Drug: Samidorphan

Samidorphan Dose 2

EXPERIMENTAL

Drug: Samidorphan

Samidorphan Dose 3

EXPERIMENTAL

Drug: Samidorphan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Oxycodone Dose 1

ACTIVE COMPARATOR

Drug: Oxycodone

Oxycodone Dose 2

ACTIVE COMPARATOR

Drug: Oxycodone

Interventions

Samidorphan DRUG

Samidorphan Dose 1; Samidorphan Dose 2; Samidorphan Dose 3

Placebo DRUG

Placebo

Oxycodone DRUG

Oxycodone Dose 1; Oxycodone Dose 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

3-carboxamido-4-hydroxynaltrexone; Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sanjeev Pathak, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)