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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: ALKS 5461 Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function

NCT02452801
View directory record Official record
Conditions
Hepatic Impairment
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Feb 3, 2016 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

NCT02218008
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
407 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
32
States / cities
Birmingham, Alabama • Colton, California • Garden Grove, California + 29 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2019 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT02218021
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Samidorphan, Placebo, Oxycodone
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Dec 1, 2014 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

NCT02479308
View directory record Official record
Conditions
Healthy
Interventions
Moxifloxacin, ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
129 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 22, 2015 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1Phase 2 Interventional

ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD

NCT01381107
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
2
States / cities
St. Petersburg, Florida • Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Aug 22, 2011 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 3 Interventional Results available

A Long-Term Safety Study of ALKS 5461

NCT02141399
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
1,485 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
123
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 105 more
Source: ClinicalTrials.gov public record
Updated Dec 13, 2018 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

NCT02158533
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
High Dose ALKS 5461, Low Dose ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
385 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
42
States / cities
Birmingham, Alabama • Tucson, Arizona • Carson, California + 37 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2019 · Synced Sep 3, 2026, 4:33 AM EDT
Terminated Phase 3 Interventional Results available

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

NCT03610048
View directory record Official record
Conditions
Refractory Major Depressive Disorder
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 72 Years
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
29
States / cities
Tucson, Arizona • Little Rock, Arkansas • Los Alamitos, California + 26 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2021 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers

NCT02272764
View directory record Official record
Conditions
Pharmacokinetics
Interventions
Itraconazole, ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Dec 11, 2014 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of ALKS 5461 in Healthy Volunteers

NCT02068105
View directory record Official record
Conditions
Pharmacokinetics
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
104 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Apr 20, 2014 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

NCT02545439
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 9, 2015 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 3 Interventional Results available

A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

NCT02085135
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
8
States / cities
Jacksonville, Florida • Orlando, Florida • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2019 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Water Consumption Study of ALKS 5461 in Healthy Volunteers

NCT02521857
View directory record Official record
Conditions
Healthy
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 9, 2015 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

NCT03188185
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, ALKS 5461 Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
278 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
30
States / cities
Tucson, Arizona • Little Rock, Arkansas • Los Alamitos, California + 27 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2021 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

NCT02158546
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
447 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
50
States / cities
Little Rock, Arkansas • Bellflower, California • Beverly Hills, California + 45 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2019 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

NCT02413281
View directory record Official record
Conditions
Healthy
Interventions
ALKS 5461, Buprenorphine, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 9, 2015 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

NCT02508506
View directory record Official record
Conditions
Renal Impairment
Interventions
ALKS 5461
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 79 Years
Enrollment
22 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
3
States / cities
Denver, Colorado • Orlando, Florida • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Feb 3, 2016 · Synced Sep 3, 2026, 4:33 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

NCT01500200
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
ALKS 5461, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
142 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
27
States / cities
Tucson, Arizona • Oceanside, California • Santa Ana, California + 24 more
Source: ClinicalTrials.gov public record
Updated May 20, 2019 · Synced Sep 3, 2026, 4:33 AM EDT