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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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