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Last Updated: March 3, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR SAMIDORPHAN

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Clinical Trials for Samidorphan

Trial ID Title Status Sponsor Phase Summary
NCT01903837 A Study of ALKS 3831 in Adults With Schizophrenia Completed Alkermes, Inc. Phase 2 This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
NCT02161718 A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder Active, not recruiting Alkermes, Inc. Phase 2 This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
NCT02218021 A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users Completed Alkermes, Inc. Phase 1 The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
NCT02504463 A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers Completed Alkermes, Inc. Phase 1 This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.
NCT02804568 A Phase 1 Safety Study in Adults With Schizophrenia Completed Alkermes, Inc. Phase 1 This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Samidorphan

Condition Name

Condition Name for
Intervention Trials
Schizophrenia 3
Healthy Volunteers 1
Healthy 1
Alcohol Use Disorder 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Schizophrenia 3
Disease 1
Alcohol Drinking 1
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Clinical Trial Locations for Samidorphan

Trials by Country

Trials by Country for
Location Trials
United States 45
Bulgaria 2
Poland 1
Czech Republic 1
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Trials by US State

Trials by US State for
Location Trials
Arkansas 3
Ohio 3
New Jersey 3
Texas 3
Mississippi 2
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Clinical Trial Progress for Samidorphan

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 1
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Clinical Trial Sponsors for Samidorphan

Sponsor Name

Sponsor Name for
Sponsor Trials
Alkermes, Inc. 5
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 5
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Serving leading biopharmaceutical companies globally:

Dow
Moodys
McKinsey
Colorcon
Baxter
Merck

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