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

February 15, 2022 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paroxetine + AVP-786
Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20.
Drug: Paroxetine
Drug: AVP-786
Experimental: AVP-786 + paroxetine
AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20
Drug: Paroxetine
Drug: AVP-786
Experimental: Duloxetine + AVP-786
Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13.
Drug: Duloxetine
Drug: AVP-786
Experimental: AVP-786 + duloxetine
AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.
Drug: Duloxetine
Drug: AVP-786

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

  • Principal Investigator: Jason Lickliter, MBBS PhD FRACP, Nucleus Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-AVP-786-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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