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

A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02174822

Enrollment

Registered

2014-06-26

Start date

2014-01-31

Completion date

2014-04-30

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-drug Interaction

Keywords

Drug-drug interaction, Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine

Brief summary

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.

Interventions

DRUGAVP-786

DRUGParoxetine

DRUGDuloxetine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects	20 days
Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.	20 days
Change in plasma concentration of duloxetine after combined dosing with AVP-786	13 days
Change in plasma concentration of AVP-786 after combined dosing with duloxetine.	13 days

Secondary

Measure	Time frame
Incidence of adverse events (AEs) for AVP-786 and paroxetine	20 days
Incidence of adverse events (AEs) for AVP-786 and duloxetine	13 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026