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

Drug-drug Interaction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174822
• Other study ID #: 14-AVP-786-101
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-drug Interaction

Intervention

Drug:
• AVP-786

• Paroxetine

• Duloxetine

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects		20 days
Primary	Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.		20 days
Primary	Change in plasma concentration of duloxetine after combined dosing with AVP-786		13 days
Primary	Change in plasma concentration of AVP-786 after combined dosing with duloxetine.		13 days
Secondary	Incidence of adverse events (AEs) for AVP-786 and paroxetine		20 days
Secondary	Incidence of adverse events (AEs) for AVP-786 and duloxetine		13 days