A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
NCT ID: NCT02479308
Last Updated: 2015-11-23
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
129 participants
INTERVENTIONAL
2015-06-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Moxifloxacin
Oral tablet
Moxifloxacin
Single administration
ALKS 5461
Sublingual tablet
ALKS 5461
Daily administration for a total of 12 dosing days
Placebo
Placebo
Placebo will be matched to Moxifloxacin or ALKS 5461
Interventions
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Moxifloxacin
Single administration
ALKS 5461
Daily administration for a total of 12 dosing days
Placebo
Placebo will be matched to Moxifloxacin or ALKS 5461
Eligibility Criteria
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Inclusion Criteria
* Is physically healthy
* Agree to abide by the contraception requirements for the duration of the study
* Additional criteria may apply
Exclusion Criteria
* Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV)
* Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality
* Have any skin condition likely to interfere with ECG electrode placement or adhesion
* Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine)
* Have used any prescription or over-the-counter (OTC) medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins), or have consumed grapefruit or any grapefruit products within 14 days prior to the first study drug dose
* Have consumed alcohol-, caffeine-, or xanthine-containing products within 24 hours prior to the first study drug dose
* Have used nicotine within 90 days prior to the first study drug dose
* Have used opioids 30 days prior to screening, or have an anticipated need for opioid medication during the study
* 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.
Arielle Stanford, 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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ALK5461-213
Identifier Type: -
Identifier Source: org_study_id