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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/NCT01787747




Registration number
NCT01787747
Ethics application status
Date submitted
6/02/2013
Date registered
11/02/2013
Date last updated
26/06/2014

Titles & IDs
Public title
Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers
Scientific title
A Phase 1, Single-center, Randomized, Double-blind, Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of AVP-786 (Deuterated Dextromethorphan) in Healthy Volunteers
Secondary ID [1] 0 0
12-AVR-132
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 Dose 1
Treatment: Drugs - AVP-786 Dose 2
Treatment: Drugs - AVP-786 Dose 1/Q Dose 1
Treatment: Drugs - AVP-786 Dose 1/Q Dose 2
Treatment: Drugs - AVP-786 Dose 2/Q Dose 2
Treatment: Drugs - AVP-923

Experimental: Cohorts A and C - Single dose (D1) followed by twice daily dosing for 7 days

Experimental: Cohorts B and D - Single dose (D1) followed by twice daily dosing for 7 days

Experimental: Cohorts E and F - Single dose (D1) followed by twice daily dosing for 7 days

Experimental: Cohorts G and I - Single dose (D1) followed by twice daily dosing for 7 days

Experimental: Cohorts H and J - Single dose (D1) followed by twice daily dosing for 7 days


Treatment: Drugs: AVP-786 Dose 1


Treatment: Drugs: AVP-786 Dose 2


Treatment: Drugs: AVP-786 Dose 1/Q Dose 1


Treatment: Drugs: AVP-786 Dose 1/Q Dose 2


Treatment: Drugs: AVP-786 Dose 2/Q Dose 2


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 parent and metabolites
Timepoint [1] 0 0
8 Days
Secondary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
8 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 and/or alcohol abuse within the past 3 years

- Use of tobacco-containing or nicotine-contining products within 6 months

- Use of any prescription of over-the-counter (OTC) medication 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
48
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 single- and multiple-dose pharmacokinetic (PK), safety and tolerability of
AVP-786 in healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01787747
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib, MD
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/NCT01787747