A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
1 other identifier
interventional
56
1 country
1
Brief Summary
To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[DM\]/quinidine sulfate \[Q\]) and paroxetine and between AVP-786 and duloxetine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedFebruary 18, 2022
June 1, 2014
2 months
June 23, 2014
February 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects
20 days
Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.
20 days
Change in plasma concentration of duloxetine after combined dosing with AVP-786
13 days
Change in plasma concentration of AVP-786 after combined dosing with duloxetine.
13 days
Secondary Outcomes (2)
Incidence of adverse events (AEs) for AVP-786 and paroxetine
20 days
Incidence of adverse events (AEs) for AVP-786 and duloxetine
13 days
Study Arms (4)
Paroxetine + AVP-786
EXPERIMENTALParoxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20.
AVP-786 + paroxetine
EXPERIMENTALAVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20
Duloxetine + AVP-786
EXPERIMENTALDuloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13.
AVP-786 + duloxetine
EXPERIMENTALAVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult males and females
- years of age
- BMI 18 - 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nucleus Network
Melbourne, Victoria, 3004, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Lickliter, MBBS PhD FRACP
Nucleus Network
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 26, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
February 18, 2022
Record last verified: 2014-06