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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/NCT02174835




Registration number
NCT02174835
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 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
Scientific title
A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers
Secondary ID [1] 0 0
13-AVR-134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AVP-786
Treatment: Drugs - AVP-923

Experimental: Cohort A - Period 1 - Twice daily dosing orally for 7 days

Active Comparator: Cohort A - Period 2 - Twice daily dosing orally for 7 days

Experimental: Cohort A - Period 3 - Twice daily dosing orally for 7 days

Experimental: Cohort B - Period 1 - Twice daily dosing orally for 7 days

Active Comparator: Cohort B - Period 2 - Twice daily dosing orally for 7 days

Experimental: Cohort B - Period 3 - Twice daily dosing orally for 7 days


Treatment: Drugs: AVP-786


Treatment: Drugs: AVP-923
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma concentrations of AVP-786
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Incidence of adverse events (AEs) for AVP-786
Timepoint [1] 0 0
7 days

Eligibility
Key inclusion criteria
- Healthy adult males

- 18 - 45 years of age

- BMI 18 - 30 kg/m2
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
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
Randomised controlled 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
Crossover
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
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02174835
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib, M.D.
Address 0 0
CMAX
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/NCT02174835