A Phase 1 Safety Study in Adults With Schizophrenia

Phase 1 Completed 42 enrolled Alkermes, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2016-06
Primary completion: 2016-08
Completion: 2016-08

Publications

Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olanzapine	Small molecule	10 mg	Oral
Subject	Olanzapine	Small molecule	20 mg	Oral
Subject	Samidorphan	Small molecule	10 mg	Oral

A Phase 1 Safety Study in Adults With Schizophrenia

Summary

Timeline

Publications

Drugs

Indications