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Effect of Itraconazole on ALKS 5461 PK in Healthy Volunteers
NCT02272764Phase 1Completed
- Sponsor
- Alkermes
- Start
- Oct 2014
- Primary completion
- Nov 2014
- Modality
- Orthosteric Ligands
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial in major depressive disorder (MDD) comparing Itraconazole + ALKS 5461 with ALKS 5461 + Placebo (2 arms). Primary endpoints: Area Under the Curve from time 0 to time t up to 48 hours, Area Under the Curve from time 0 to infinity up to 48 hours and 1 more. Started Oct 2014; status: completed.
02
Drugs
buprenorphine + samidorphan
03
Conditions
major depressive disorder (MDD)
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