A Study of ALKS 5461 in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Pharmacokinetics

In brief

This is a study to test the safety of ALKS 5461 in healthy adults.

Key facts

Study ID

NCT02068105

Run by

Alkermes, Inc.

People needed

104

Starts

2014-01-01

Expected to finish

2014-03-01

Last updated by the study team

2014-04-21

Who can join

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

You may qualify if…

• Be in good physical health
• Body mass index of 18-30 kg/m2
• Agree to use an approved method of birth control for the duration of the study
• Additional criteria may apply

You may not qualify if…

• Currently pregnant or breastfeeding
• History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
• Current or history of any clinically significant medical or psychiatric condition
• Current abuse or dependence on alcohol or any illicit drugs
• Have used nicotine within 90 days
• Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
• Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
• Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
• Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, 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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