A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
NCT ID: NCT02174835
Last Updated: 2014-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2013-09-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Cohort A - Period 1
Twice daily dosing orally for 7 days
AVP-786
Cohort A - Period 2
Twice daily dosing orally for 7 days
AVP-923
Cohort A - Period 3
Twice daily dosing orally for 7 days
AVP-786
Cohort B - Period 1
Twice daily dosing orally for 7 days
AVP-786
Cohort B - Period 2
Twice daily dosing orally for 7 days
AVP-923
Cohort B - Period 3
Twice daily dosing orally for 7 days
AVP-786
Interventions
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AVP-786
AVP-923
Eligibility Criteria
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Inclusion Criteria
* 18 - 45 years of age
* BMI 18 - 30 kg/m2
Exclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Avanir Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sepehr Shakib, M.D.
Role: PRINCIPAL_INVESTIGATOR
CMAX
Locations
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CMAX
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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13-AVR-134
Identifier Type: -
Identifier Source: org_study_id
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