A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
- Registration Number
- NCT02174835
- Lead Sponsor
- Avanir Pharmaceuticals
- Brief Summary
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[DM\]/quinidine sulfate \[Q\]) in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
- Healthy adult males
- 18 - 45 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort A - Period 1 AVP-786 Twice daily dosing orally for 7 days Cohort B - Period 3 AVP-786 Twice daily dosing orally for 7 days Cohort A - Period 2 AVP-923 Twice daily dosing orally for 7 days Cohort A - Period 3 AVP-786 Twice daily dosing orally for 7 days Cohort B - Period 1 AVP-786 Twice daily dosing orally for 7 days Cohort B - Period 2 AVP-923 Twice daily dosing orally for 7 days
- Primary Outcome Measures
Name Time Method Plasma concentrations of AVP-786 7 days
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) for AVP-786 7 days
Trial Locations
- Locations (1)
CMAX
🇦🇺Adelaide, South Australia, Australia