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

Completed · Phase 1 · Has a placebo group

Conditions studied: Pharmacokinetics

In brief

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

Key facts

Study ID

NCT02272764

Run by

Alkermes, Inc.

People needed

24

Starts

2014-10-01

Expected to finish

2014-11-01

Last updated by the study team

2014-12-12

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/m2
• 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…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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