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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avanir Pharmaceuticals
• Treatments: Dextromethorphan; Hydroxyitraconazole; Itraconazole; Quinidine

Criteria

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