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

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

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.

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

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