Trial intelligence / Profile preview

PK and Safety of ALKS 5461 in Hepatic Impairment

NCT02452801Phase 1Completed

Sponsor
Alkermes
Start
May 2015
Primary completion
Dec 2015
Modality
Orthosteric Ligands
Countries
1
01

Overview

Phase 1, open-label, single-arm trial of buprenorphine and samidorphan in major depressive disorder (MDD), sponsored by Alkermes. Primary endpoints: Area under the plasma concentration versus time curve from time 0 to infinity, Area under the plasma concentration versus time curve from time 0 to time of last measureable concentration and 1 more. Started May 2015; status: completed.

02

Drugs

buprenorphinesamidorphan
03

Conditions

major depressive disorder (MDD)

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