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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02174822




Registration number
NCT02174822
Ethics application status
Date submitted
23/06/2014
Date registered
26/06/2014
Date last updated
18/02/2022

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
Sex
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
Other
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
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
56
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
Otsuka Pharmaceutical Development & Commercialization, Inc.
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02174822