Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.

Detailed Description
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A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.

Official Title
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A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AVP-923
* Drug: AVP-786
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males and females, 18 to 55 years of age Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females) Exclusion Criteria: History or presence of significant disease History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose 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: 55 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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 - Period 1<br>AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 | Drug: AVP-923<br> <br> Drug: Itraconazole<br> <br> * Other names: Sporanex;|
| Experimental: Sequence 1 - Period 2 (after 3-week washout)<br>AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 | Drug: AVP-786<br> <br> Drug: Itraconazole<br> <br> * Other names: Sporanex;|
| Experimental: Sequence 2 - Period 1<br>AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 | Drug: AVP-786<br> <br> Drug: Itraconazole<br> <br> * Other names: Sporanex;|
| Experimental: Sequence 2 - Period 2 (after 3-week washout)<br>AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 | Drug: AVP-923<br> <br> Drug: Itraconazole<br> <br> * Other names: Sporanex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma concentration of AVP-923 after dosing in combination with itraconazole |  | 16 Days | 
| Change in plasma concentration of AVP-786 after dosing in combination with itraconazole |  | 16 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) for AVP-923 and itraconazole |  | 16 Days | 
| Incidence of adverse events (AEs) for AVP-786 and itraconazole |  | 16 Days | 

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