CLINICAL TRIALS PROFILE FOR AVP-786

Clinical Trials for AVP-786

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01787747 ↗	Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers	Completed	Avanir Pharmaceuticals	Phase 1	To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.
NCT02153502 ↗	Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment	Completed	Avanir Pharmaceuticals	Phase 2	The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.
NCT02174822 ↗	A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects	Completed	Avanir Pharmaceuticals	Phase 1	To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.
NCT02174835 ↗	A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers	Completed	Avanir Pharmaceuticals	Phase 1	To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
NCT02336347 ↗	A Phase 1 Study Comparing AVP-786 With AVP-923	Completed	Avanir Pharmaceuticals	Phase 1	To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.
NCT02402595 ↗	Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts	Completed	Avanir Pharmaceuticals	Phase 1	The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.

Clinical Trial Conditions for AVP-786

Condition Name

Condition Name
Intervention	Trials
Agitation in Patients With Dementia of the Alzheimer's Type	6
Healthy	3
Schizophrenia	2
Intermittent Explosive Disorder	1

Condition MeSH

Condition MeSH
Intervention	Trials
Psychomotor Agitation	7
Dementia	6
Alzheimer Disease	6
Schizophrenia	2

Clinical Trial Locations for AVP-786

Trials by Country

Trials by Country
Location	Trials
United States	209
Canada	6
Poland	4
Spain	4
Australia	4

Trials by US State

Trials by US State
Location	Trials
Florida	11
New York	10
Georgia	10
California	10
Texas	9

Clinical Trial Progress for AVP-786

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	6
Phase 2/Phase 3	1
Phase 2	5

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	9
Recruiting	6
Terminated	2

Clinical Trial Sponsors for AVP-786

Sponsor Name

Sponsor Name
Sponsor	Trials
Avanir Pharmaceuticals	17

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	17