A Study of ALKS 5461 in Healthy Volunteers

A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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