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

A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers

This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.

Inclusion Criteria:

• Has a body mass index (BMI) of 18.0 - 30.0 kg/m2
• 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:

• Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
• Is currently pregnant or breastfeeding
• Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
• Has a lifetime history of opioid abuse or dependence
• Has current abuse or dependence on alcohol or any drugs
• Has used nicotine within 90 days prior to randomization
• Additional criteria may apply