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ALKS 5461

DRUG16 trials

Sponsors

Alkermes, Inc.

Conditions

HealthyHealthy VolunteersHepatic ImpairmentMajor Depressive DisorderPharmacokineticsRefractory Major Depressive DisorderRenal Impairment

Phase 1

ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
CompletedNCT01381107
Alkermes, Inc.Major Depressive Disorder
Start: 2011-05-31End: 2011-07-31Target: 32Updated: 2011-08-23
A Study of ALKS 5461 in Healthy Volunteers
CompletedNCT02068105
Alkermes, Inc.Pharmacokinetics
Start: 2014-01-31End: 2014-03-31Updated: 2014-04-21
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
CompletedNCT02272764
Alkermes, Inc.Pharmacokinetics
Start: 2014-10-31End: 2014-11-30Updated: 2014-12-12
A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users
CompletedNCT02413281
Alkermes, Inc.Healthy
Start: 2015-03-31End: 2015-09-30Updated: 2015-11-10
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
CompletedNCT02452801
Alkermes, Inc.Hepatic Impairment
Start: 2015-05-31End: 2015-12-31Updated: 2016-02-04
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
CompletedNCT02479308
Alkermes, Inc.Healthy
Start: 2015-06-30End: 2015-10-31Updated: 2015-11-23
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
CompletedNCT02508506
Alkermes, Inc.Renal Impairment
Start: 2015-07-31End: 2015-12-31Updated: 2016-02-04
A Water Consumption Study of ALKS 5461 in Healthy Volunteers
CompletedNCT02521857
Alkermes, Inc.Healthy
Start: 2015-07-31End: 2015-09-30Updated: 2015-11-10
A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
CompletedNCT02545439
Alkermes, Inc.Healthy Volunteers
Start: 2015-07-31End: 2015-10-31Updated: 2015-11-10

Phase 2

A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
CompletedNCT01500200
Alkermes, Inc.Major Depressive Disorder
Start: 2011-12-31End: 2013-03-31Updated: 2019-05-21

Phase 3

A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
CompletedNCT02085135
Alkermes, Inc.Major Depressive Disorder
Start: 2014-02-28End: 2014-09-30Updated: 2019-08-14
A Long-Term Safety Study of ALKS 5461
CompletedNCT02141399
Alkermes, Inc.Major Depressive Disorder
Start: 2014-05-31End: 2017-11-20Updated: 2018-12-14
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
CompletedNCT02158546
Alkermes, Inc.Major Depressive Disorder
Start: 2014-05-31End: 2015-12-31Updated: 2019-06-25
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
CompletedNCT02218008
Alkermes, Inc.Major Depressive Disorder
Start: 2014-07-31End: 2016-10-31Updated: 2019-08-14
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
CompletedNCT03188185
Alkermes, Inc.Major Depressive Disorder
Start: 2017-06-12End: 2020-03-05Updated: 2021-04-08
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
TerminatedNCT03610048
Alkermes, Inc.Refractory Major Depressive Disorder
Start: 2018-08-09End: 2020-05-01Updated: 2021-07-16

Related Papers

50 Adjunctive Buprenorphine/Samidorphan Combination in Patients with Major Depressive Disorder: Phase 3 Long-term Extension Study Results
CNS Spectrums2019-02-012 citations
5 Clinical Evaluation of the Abuse Potential of Buprenorphine/Samidorphan Combination
CNS Spectrums2019-02-01
Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial
The Journal of Clinical Pharmacology2018-08-1312 citations