A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Phase 1
Completed
- Conditions
- Drug-drug Interaction
- Interventions
- Registration Number
- NCT02174822
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paroxetine + AVP-786 AVP-786 Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20. Paroxetine + AVP-786 Paroxetine Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20. AVP-786 + paroxetine Paroxetine AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20 Duloxetine + AVP-786 AVP-786 Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13. Duloxetine + AVP-786 Duloxetine Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13. AVP-786 + duloxetine Duloxetine AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13. AVP-786 + paroxetine AVP-786 AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20 AVP-786 + duloxetine AVP-786 AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence of adverse events (AEs) for AVP-786 and paroxetine 20 days Incidence of adverse events (AEs) for AVP-786 and duloxetine 13 days
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Melbourne, Victoria, Australia