A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

Otsuka Pharmaceutical Development & Commercialization, Inc.56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Drug-drug Interaction

Interventions

AVP-786DRUG

ParoxetineDRUG

DuloxetineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult males and females * 18 - 50 years of age * BMI 18 - 30 kg/m2 Exclusion Criteria: * History or presence of significant disease * History of substance abuse and/or alcohol abuse with the past 3 years * Use of tobacco-containing or nicotine-containing products within 6 months * Use of any prescription or the over-the-counter medications within 14 days

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects

Time frame: 20 days

Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.

Time frame: 20 days

Change in plasma concentration of duloxetine after combined dosing with AVP-786

Time frame: 13 days

Change in plasma concentration of AVP-786 after combined dosing with duloxetine.

Time frame: 13 days

Secondary Outcomes

Incidence of adverse events (AEs) for AVP-786 and paroxetine

Time frame: 20 days

Incidence of adverse events (AEs) for AVP-786 and duloxetine

Time frame: 13 days

Data from ClinicalTrials.gov

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