Expired Study
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Overland Park, Kansas 66212


This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.


Inclusion Criteria: - Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2 - 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 lifetime history of substance abuse disorder - Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period - Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception or prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start - Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study - Has used alcohol within 72 hours prior to any inpatient period - Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day) - Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone) - Additional criteria may apply



Primary Contact:

Study Director
Arielle Stanford, MD
Alkermes, Inc.

Backup Contact:


Location Contact:

Overland Park, Kansas 66212
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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