Trial intelligence / Profile preview

Impact of CYP3A4 Induction on ALKS 5461 PK

NCT02545439Phase 1Completed

Sponsor
Alkermes
Start
Jul 2015
Primary completion
Oct 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 Curve to Infinity up to 72 hours, Area Under the Curve to Last Measurable Concentration up to 72 hours and 1 more. Started Jul 2015; status: completed.

02

Drugs

buprenorphinesamidorphan
03

Conditions

major depressive disorder (MDD)

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