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

NCT02272764 — Phase 1, Completed, 24 participants, Alkermes, Inc.

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

Registry	NCT02272764
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	24 (Actual)
Sponsor	Alkermes, Inc. (Industry)
Conditions	Pharmacokinetics
Interventions	Itraconazole, ALKS 5461 (Drug)
Dates	start 2014-10-01, primary completion 2014-11-01, completion 2014-11-01, first posted 2014-10-23, last updated 2014-12-12
Locations	1 site in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Itraconazole	Other	Drug: Itraconazole	Itraconazole or placebo
ALKS 5461	Experimental	Drug: ALKS 5461	ALKS 5461 or placebo Sublingual tablet

Itraconazole (Drug), also known as Itraconazole or placebo: Administered orally in a crossover design
ALKS 5461 (Drug), also known as ALKS 5461 or placebo: Administered sublingually in a crossover design

+Outcome measures

Primary outcomes

Drug-Drug Interaction - AUC0-t [Up to 48 hours]: Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - AUC0-inf [Up to 48 hours]: Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - Cmax [Up to 48 hours]: Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole

Secondary outcomes

Safety and tolerability will be measured by incidence of adverse events [Up to 32 Days]

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Alkermes Investigational Site	Overland Park, Kansas	United States

+Investigators

Sanjeev Pathak, MD, Study director, Alkermes, Inc.