A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Paroxetine + AVP-786 Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20. |
Drug: AVP-786
Drug: Paroxetine
|
Experimental: AVP-786 + paroxetine AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20 |
Drug: AVP-786
Drug: Paroxetine
|
Experimental: Duloxetine + AVP-786 Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13. |
Drug: AVP-786
Drug: Duloxetine
|
Experimental: AVP-786 + duloxetine AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13. |
Drug: AVP-786
Drug: Duloxetine
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Incidence of adverse events (AEs) for AVP-786 and paroxetine [20 days]
- Incidence of adverse events (AEs) for AVP-786 and duloxetine [13 days]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Nucleus Network | Melbourne | Victoria | Australia | 3004 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
- Principal Investigator: Jason Lickliter, MBBS PhD FRACP, Nucleus Network
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-AVP-786-101