Healthy
Conditions
Keywords
Drug-drug interaction, Healthy Volunteers, Pharmacokinetics, deuterated dextromethorphan, dextromethorphan, dextromethorphan with quinidine, deuterated dextromethorphan with quinidine, itraconazole
Brief 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.
Detailed description
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed