Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
NCT ID: NCT02402595
Last Updated: 2017-03-20
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
24 participants
INTERVENTIONAL
2015-03-31
2015-07-31
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
OTHER
TRIPLE
Study Groups
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Sequence 1 - Period 1
AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
AVP-923
Itraconazole
Sequence 1 - Period 2 (after 3-week washout)
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
AVP-786
Itraconazole
Sequence 2 - Period 1
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
AVP-786
Itraconazole
Sequence 2 - Period 2 (after 3-week washout)
AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
AVP-923
Itraconazole
Interventions
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AVP-923
AVP-786
Itraconazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)
Exclusion Criteria
* History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
* Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
* Use of any prescription or the over-the-counter medications within 14 days
18 Years
55 Years
ALL
Yes
Sponsors
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Avanir Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Kankam, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vince and Associates Clinical Research Inc.
Locations
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Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Countries
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Other Identifiers
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15-AVP-786-103
Identifier Type: -
Identifier Source: org_study_id
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