A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
NCT ID: NCT02504463
Last Updated: 2015-09-18
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
10 participants
INTERVENTIONAL
2015-06-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Samidorphan IV
Samidorphan solution for IV administration
Samidorphan IV
Single IV administration
Samidorphan sublingual
\[14c\]-Samidorphan for sublingual administration
[14c]-Samidorphan sublingual
Single sublingual administration containing radiolabel
Samidorphan oral
\[14c\]-Samidorphan for oral administration
[14c]-Samidorphan oral
Single oral administration containing radiolabel
Interventions
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Samidorphan IV
Single IV administration
[14c]-Samidorphan sublingual
Single sublingual administration containing radiolabel
[14c]-Samidorphan oral
Single oral administration containing radiolabel
Eligibility Criteria
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Inclusion Criteria
* Generally good health
* Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
* Additional criteria may apply
Exclusion Criteria
* History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
* History of oral or gastrointestinal disease
* Irregular bowel or bladder function
* History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
* Current or pending legal charges or probation that would interfere with study conduct
* Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission
* Tobacco or nicotine use within 90 days
* Anticipated need for prescription medicines during the study period
* Additional criteria may apply
18 Years
55 Years
MALE
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Arielle Stanford, MD
Role: STUDY_DIRECTOR
Alkermes Medical Director
Locations
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Alkermes Investigational Site
Austin, Texas, United States
Countries
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Other Identifiers
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ALK33-B107
Identifier Type: -
Identifier Source: org_study_id
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