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

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ClinicalTrials.gov Identifier: NCT02272764
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
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Brief Summary:
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Itraconazole Drug: ALKS 5461 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Itraconazole
Itraconazole or placebo
 Drug: Itraconazole
Administered orally in a crossover design
Other Name: Itraconazole or placebo
Experimental: ALKS 5461
ALKS 5461 or placebo Sublingual tablet
 Drug: ALKS 5461
Administered sublingually in a crossover design
Other Name: ALKS 5461 or placebo


Outcome Measures
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Primary Outcome Measures :
  1. Drug-Drug Interaction - AUC0-t [ Time Frame: 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

  2. Drug-Drug Interaction - AUC0-inf [ Time Frame: 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

  3. Drug-Drug Interaction - Cmax [ Time Frame: Up to 48 hours ]
    Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole


Secondary Outcome Measures :
  1. Safety and tolerability will be measured by incidence of adverse events [ Time Frame: Up to 32 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272764


Locations
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United States, Kansas
Alkermes Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.
More Information
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02272764    
Other Study ID Numbers: ALK5461-214
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors