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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Drug-drug Interaction

Intervention / Treatment
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* Drug: AVP-786
* Drug: Paroxetine
* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-drug interaction, Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine