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
60 participants
INTERVENTIONAL
2016-09-30
2017-07-20
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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ALKS 3831
Oral, bilayer tablet
ALKS 3831
Daily dosing for 21 consecutive days
Olanzapine
Oral, bilayer tablet
Olanzapine
Daily dosing for 21 consecutive days
Placebo
Oral, bilayer tablet
Placebo
Daily dosing for 21 consecutive days
Interventions
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ALKS 3831
Daily dosing for 21 consecutive days
Olanzapine
Daily dosing for 21 consecutive days
Placebo
Daily dosing for 21 consecutive days
Eligibility Criteria
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Inclusion Criteria
* No prior history of regular smoking or nicotine use
* Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
* Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
* Additional criteria may apply
Exclusion Criteria
* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
* Has a lifetime history of diabetes
* Has a known risk of narrow-angle glaucoma
* Has a clinically significant illness within 30 days prior to screening or admission to the clinic
* Has a history of dependence on any substance other than caffeine
* Has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period
* Has a positive urine drug screen for drugs of abuse at screening or admission to the study site
* Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic
* Has had any vaccinations in the 4 weeks prior to screening or admission to the clinic
* Chronic use of non-steroid anti-inflammatory drugs (NSAIDs) and acetaminophen, except for low-dose Aspirin is not allowed
* Use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by Investigator
* Has prior use of any antipsychotic medication, including on and off label uses
* Additional criteria may apply
18 Years
40 Years
ALL
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David McDonnell, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Chula Vista, California, United States
Countries
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Other Identifiers
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ALK3831-A108
Identifier Type: -
Identifier Source: org_study_id
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