Status:
COMPLETED
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
Lead Sponsor:
Alkermes, Inc.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02272764
Start Date
October 1 2014
End Date
November 1 2014
Last Update
December 12 2014
Active Locations (1)
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1
Alkermes Investigational Site
Overland Park, Kansas, United States, 66212