A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
NCT ID: NCT02272764
Last Updated: 2014-12-12
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
2014-10-31
2014-11-30
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
TREATMENT
QUADRUPLE
Study Groups
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Itraconazole
Itraconazole or placebo
Itraconazole
Administered orally in a crossover design
ALKS 5461
ALKS 5461 or placebo Sublingual tablet
ALKS 5461
Administered sublingually in a crossover design
Interventions
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Itraconazole
Administered orally in a crossover design
ALKS 5461
Administered sublingually in a crossover design
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is in good physical health
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply
Exclusion Criteria
* Is currently pregnant or breastfeeding
* Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
* Has a lifetime history of opioid abuse or dependence
* Has current abuse or dependence on alcohol or any drugs
* Has used nicotine within 90 days prior to randomization
* Additional criteria may apply
18 Years
50 Years
ALL
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjeev Pathak, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Overland Park, Kansas, United States
Countries
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Other Identifiers
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ALK5461-214
Identifier Type: -
Identifier Source: org_study_id