Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
104 participants
INTERVENTIONAL
2014-01-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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ALKS 5461-A
ALKS 5461
Sublingual tablet
ALKS 5461-B
ALKS 5461
Sublingual tablet
ALKS 5461 Dose 1
ALKS 5461
Sublingual tablet
ALKS 5461 Dose 2
ALKS 5461
Sublingual tablet
ALKS 5461 Dose 3
ALKS 5461
Sublingual tablet
Placebo
Placebo
Sublingual tablet
Interventions
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ALKS 5461
Sublingual tablet
Placebo
Sublingual tablet
Eligibility Criteria
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Inclusion Criteria
* Body mass index of 18-30 kg/m2
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply
Exclusion Criteria
* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
* Current or history of any clinically significant medical or psychiatric condition
* Current abuse or dependence on alcohol or any illicit drugs
* Have used nicotine within 90 days
* Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
* 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 used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
* Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Additional criteria may apply
18 Years
50 Years
ALL
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Randall Marshall, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Overland Park, Kansas, United States
Countries
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Other Identifiers
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ALK5461-209
Identifier Type: -
Identifier Source: org_study_id
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