A Study of the Abuse Liability Potential of Samidorphan i... | NCT02218021

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

NCT02218021

Sponsor

Alkermes, Inc.

Status

Completed

Last Update Posted

Dec 2, 2014Estimated

Enrollment

59Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Samidorphan
Placebo
Oxycodone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Aug 14, 2014

First Submission Date that Met QC Criteria

Aug 14, 2014

First Posted Date

Aug 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Samidorphan	Drug		Samidorphan Dose 1 Samidorphan Dose 2 Samidorphan Dose 3
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)		Approximately 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety: Incidence of adverse events (AEs)		Approximately 5.5 weeks
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite		Approximately 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sanjeev Pathak, MD	Alkermes, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alkermes Investigational Site		Overland Park	Kansas	66212	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000606131	3-carboxamido-4-hydroxynaltrexone
D010098	Oxycodone

Ancestor Terms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided