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A Phase 1 Study Comparing AVP-786 With AVP-923

Sponsor
Avanir Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02336347
Collaborator
(none)
62
Enrollment
1
Location
4
Arms
10
Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Official Title:
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 - Period 1

Twice daily dosing of AVP-786 orally for 8 days

Drug: AVP-786
Other Names:
  • deuterated (d6)-dextropmethorphan/quindine sulfate

    		•
    Active Comparator: Group 1 - Period 2

    Twice daily dosing of AVP-923 orally for 8 days

    Drug: AVP-923
    Other Names:
  • dextromethorphan/quinidine

    		•
    Active Comparator: Group 2 - Period 1

    Twice daily dosing of AVP-923 orally for 8 days

    Drug: AVP-923
    Other Names:
  • dextromethorphan/quinidine

    		•
    Experimental: Group 2 - Period 2

    Twice daily dosing of AVP-786 orally for 8 days

    Drug: AVP-786
    Other Names:
  • deuterated (d6)-dextropmethorphan/quindine sulfate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK of d6-DM in AVP-786 compared to DM in AVP-923 [8 days]

    Secondary Outcome Measures

    1. PK of metabolites [8 days]

    2. Safety and tolerability [8 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy adult males or females

    • 18 - 60 years of age

    • BMI 18 - 32 kg/m2

    Exclusion Criteria:

    • History or presence of significant disease

    • History of substance abuse and/or alcohol abuse with the past 2 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Dallas Clinical Research Unit Dallas Texas United States 75247

    Sponsors and Collaborators

    • Avanir Pharmaceuticals

    Investigators

    • Study Director: Nadine Knowles, Avanir Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Avanir Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02336347
    Other Study ID Numbers:
    • 14-AVP-786-102
    First Posted:
    Jan 13, 2015
    Last Update Posted:
    Jul 13, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by Avanir Pharmaceuticals
    Pharmacokinetics
    Healthy Volunteers
    deuterated dextromethorphan
    deuterated dextromethorphan with quinidine
    Additional relevant MeSH terms:
    Quinidine
    Dextromethorphan

    Study Results

    No Results Posted as of Jul 13, 2015