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

Sponsor
Alkermes, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02272764
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
1
Duration (Months)
23.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Itraconazole

Itraconazole or placebo

Drug: Itraconazole
Administered orally in a crossover design
Other Names:
  • Itraconazole or placebo

    		•
    Experimental: ALKS 5461

    ALKS 5461 or placebo Sublingual tablet

    Drug: ALKS 5461
    Administered sublingually in a crossover design
    Other Names:
  • ALKS 5461 or placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Drug-Drug Interaction - Cmax [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 [Up to 32 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Alkermes Investigational Site Overland Park Kansas United States 66212

    Sponsors and Collaborators

    • Alkermes, Inc.

    Investigators

    • Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alkermes, Inc.
    ClinicalTrials.gov Identifier:
    NCT02272764
    Other Study ID Numbers:
    • ALK5461-214
    First Posted:
    Oct 23, 2014
    Last Update Posted:
    Dec 12, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Itraconazole
    Hydroxyitraconazole

    Study Results

    No Results Posted as of Dec 12, 2014