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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02174822




Registration number
NCT02174822
Ethics application status
Date submitted
23/06/2014
Date registered
26/06/2014
Date last updated
26/06/2014

Titles & IDs
Public title
A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Scientific title
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
Secondary ID [1] 0 0
14-AVP-786-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-drug Interaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AVP-786
Treatment: Drugs - Paroxetine
Treatment: Drugs - Duloxetine

Experimental: Paroxetine + AVP-786 - Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20.

Experimental: AVP-786 + paroxetine - AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20

Experimental: Duloxetine + AVP-786 - Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13.

Experimental: AVP-786 + duloxetine - AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.


Treatment: Drugs: AVP-786


Treatment: Drugs: Paroxetine


Treatment: Drugs: Duloxetine


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects
Timepoint [1] 0 0
20 days
Primary outcome [2] 0 0
Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.
Timepoint [2] 0 0
20 days
Primary outcome [3] 0 0
Change in plasma concentration of duloxetine after combined dosing with AVP-786
Timepoint [3] 0 0
13 days
Primary outcome [4] 0 0
Change in plasma concentration of AVP-786 after combined dosing with duloxetine.
Timepoint [4] 0 0
13 days
Secondary outcome [1] 0 0
Incidence of adverse events (AEs) for AVP-786 and paroxetine
Timepoint [1] 0 0
20 days
Secondary outcome [2] 0 0
Incidence of adverse events (AEs) for AVP-786 and duloxetine
Timepoint [2] 0 0
13 days

Eligibility
Key inclusion criteria
- Healthy adult males and females

- 18 - 50 years of age

- BMI 18 - 30 kg/m2
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avanir Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02174822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MBBS PhD FRACP
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications