A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
NCT02272764 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2014-12-12
Summary
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
Conditions
- Pharmacokinetics
Interventions
- DRUG
-
Itraconazole
Administered orally in a crossover design
- DRUG
-
ALKS 5461
Administered sublingually in a crossover design
Sponsors & Collaborators
-
Alkermes, Inc.
lead INDUSTRY
Principal Investigators
-
Sanjeev Pathak, MD · Alkermes, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2014-11-30
- Completion
- 2014-11-30
Countries
- United States
Study Locations
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