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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE October 23, 2014
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
  • 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
  • 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
  • Drug-Drug Interaction - Cmax [ Time Frame: Up to 48 hours ]
    Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02272764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Safety and tolerability will be measured by incidence of adverse events [ Time Frame: Up to 32 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
Official Title  ICMJE A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers
Brief Summary This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: Itraconazole
    Administered orally in a crossover design
    Other Name: Itraconazole or placebo
  • Drug: ALKS 5461
    Administered sublingually in a crossover design
    Other Name: ALKS 5461 or placebo
Study Arms  ICMJE
  • Itraconazole
    Itraconazole or placebo
    Intervention: Drug: Itraconazole
  • Experimental: ALKS 5461
    ALKS 5461 or placebo Sublingual tablet
    Intervention: Drug: ALKS 5461
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272764
Other Study ID Numbers  ICMJE ALK5461-214
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sanjeev Pathak, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP