16 completed, 1 terminated. 9 Phase 1, 7 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 9 |
| Phase 3 | 7 | Completed 6, Terminated 1 |
| Phase 2 | 2 | Completed 2 |
Follow this drug Literature Review of ALKS 5461 trials Research Report on ALKS 5461
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD) ALKS 5461 - Refractory Major Depressive Disorder | Phase 3 | Terminated | Alkermes, Inc. | 175 | 2018-08-09 | 2021-07-16 |
| A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD) ALKS 5461, ALKS 5461 Placebo - Major Depressive Disorder | Phase 3 | Completed | Alkermes, Inc. | 278 | 2017-06-12 | 2021-04-08 |
| A Water Consumption Study of ALKS 5461 in Healthy Volunteers ALKS 5461 - Healthy | Phase 1 | Completed | Alkermes, Inc. | 30 | 2015-07-01 | 2015-11-10 |
| A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers ALKS 5461 - Healthy Volunteers | Phase 1 | Completed | Alkermes, Inc. | 24 | 2015-07-01 | 2015-11-10 |
| Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function ALKS 5461 - Renal Impairment | Phase 1 | Completed | Alkermes, Inc. | 22 | 2015-07-01 | 2016-02-04 |
| A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers Moxifloxacin, ALKS 5461, Placebo - Healthy | Phase 1 | Completed | Alkermes, Inc. | 129 | 2015-06-01 | 2015-11-23 |
| Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function ALKS 5461 - Hepatic Impairment | Phase 1 | Completed | Alkermes, Inc. | 40 | 2015-05-01 | 2016-02-04 |
| A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users ALKS 5461, Buprenorphine, Placebo - Healthy | Phase 1 | Completed | Alkermes, Inc. | 56 | 2015-03-01 | 2015-11-10 |
| A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers Itraconazole, ALKS 5461 - Pharmacokinetics | Phase 1 | Completed | Alkermes, Inc. | 24 | 2014-10-01 | 2014-12-12 |
| A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study ALKS 5461, Placebo - Major Depressive Disorder | Phase 3 | Completed | Alkermes, Inc. | 407 | 2014-07-01 | 2019-08-14 |
| A Long-Term Safety Study of ALKS 5461 ALKS 5461 - Major Depressive Disorder | Phase 3 | Completed | Alkermes, Inc. | 1485 | 2014-05-01 | 2018-12-14 |
| A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study High Dose ALKS 5461, Low Dose ALKS 5461, Placebo - Major Depressive Disorder | Phase 3 | Completed | Alkermes, Inc. | 385 | 2014-05-01 | 2019-08-14 |
| A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study ALKS 5461, Placebo - Major Depressive Disorder | Phase 3 | Completed | Alkermes, Inc. | 447 | 2014-05-01 | 2019-06-25 |
| A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD) ALKS 5461 - Major Depressive Disorder | Phase 3 | Completed | Alkermes, Inc. | 66 | 2014-02-01 | 2019-08-14 |
| A Study of ALKS 5461 in Healthy Volunteers ALKS 5461, Placebo - Pharmacokinetics | Phase 1 | Completed | Alkermes, Inc. | 104 | 2014-01-01 | 2014-04-21 |
| A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD) ALKS 5461, Placebo - Major Depressive Disorder | Phase 2 | Completed | Alkermes, Inc. | 142 | 2011-12-01 | 2019-05-21 |
| ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD ALKS 5461, Placebo - Major Depressive Disorder | Phase 1 / Phase 2 | Completed | Alkermes, Inc. | 32 | 2011-05-01 | 2011-08-23 |
Depressive Disorder, Major (9) · Depression (5) · Renal Insufficiency (1)
Alkermes, Inc. (17)
United States (17) · Australia (4) · Canada (4) · Puerto Rico (4) · Bulgaria (2) · Germany (2) · Hungary (1) · Poland (1)
Sanjeev Pathak, MD (10) · Arielle Stanford, MD (4) · Randall Marshall, MD (1) · Richard Leigh-Pemberton, M.D. (1) · Richard Leigh-Pemberton, MD (1)