A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT02545439

Run by

Alkermes, Inc.

People needed

24

Starts

2015-07-01

Expected to finish

2015-10-01

Last updated by the study team

2015-11-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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