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Completed

NCT Number: NCT02174822

A Phase 1, Drug Interaction Study Between AVP-786 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.

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Key information

Conditions

Drug-drug Interaction

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVP-786

Drug

paroxetine

Drug

Duloxetine

Drug

Primary outcomes

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

    Time frame: 20 days

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

    Time frame: 20 days

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

    Time frame: 13 days

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

    Time frame: 13 days

Secondary outcomes

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

    Time frame: 20 days

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

    Time frame: 13 days

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2014
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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