NCT02413281

Brief Summary

This study will evaluate the abuse potential of ALKS 5461.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

April 7, 2015

Last Update Submit

November 9, 2015

Conditions

Healthy

Keywords

Healthy VolunteerAbuse LiabilityALKS 5461Alkermes

Outcome Measures

Primary Outcomes (1)

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

    Approximately 14 weeks

Secondary Outcomes (2)

  • Safety: Incidence of adverse events (AEs)

    Up to 14 weeks

  • Pharmacokinetics: Plasma concentrations of ALKS 5461

    Up to 14 weeks

Study Arms (6)

ALKS 5461 Dose 1

EXPERIMENTAL

Sublingual tablets

Drug: ALKS 5461

ALKS 5461 Dose 2

EXPERIMENTAL

Sublingual tablets

Drug: ALKS 5461

ALKS 5461 Dose 3

EXPERIMENTAL

Sublingual tablets

Drug: ALKS 5461

Buprenorphine Dose 1

ACTIVE COMPARATOR

Sublingual tablets

Drug: Buprenorphine

Buprenorphine Dose 2

ACTIVE COMPARATOR

Sublingual tablets

Drug: Buprenorphine

Placebo

PLACEBO COMPARATOR

Sublingual tablets

Drug: Placebo

Interventions

ALKS 5461DRUG

Sublingual tablets, single administration

ALKS 5461 Dose 1ALKS 5461 Dose 2ALKS 5461 Dose 3
BuprenorphineDRUG

Sublingual tablets, single administration

Buprenorphine Dose 1Buprenorphine Dose 2
PlaceboDRUG

Sublingual tablets, single administration

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg
  • Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime
  • Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal
  • Be willing and able to abide by all study requirements and restrictions
  • Additional criteria may apply

You may not qualify if:

  • Have evidence of drug or alcohol dependence within the past 2 years
  • Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic
  • Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting
  • Be currently pregnant, breastfeeding, or planning to become pregnant during the study
  • Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone)
  • Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  • Have donated or lost more than 500 mL whole blood
  • Additional criteria may apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

  • Pathak S, Vince B, Kelsh D, Shram MJ, Setnik B, Lu H, Nangia N, Stanford AD, Ehrich E. Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial. J Clin Pharmacol. 2019 Feb;59(2):206-217. doi: 10.1002/jcph.1280. Epub 2018 Aug 13.

    PMID: 30102427DERIVED

MeSH Terms

Interventions

ALKS 5461Buprenorphine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic 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

April 7, 2015

First Posted

April 9, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

US(1)