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A Study of ALKS 5461 in Healthy Volunteers

Sponsor
Alkermes, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02068105
Collaborator
(none)
104
Enrollment
1
Location
6
Arms
1.9
Duration (Months)
53.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to test the safety of ALKS 5461 in healthy adults.

Condition or Disease Intervention/Treatment Phase
  • Drug: ALKS 5461
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALKS 5461-A

Drug: ALKS 5461
Sublingual tablet
Experimental: ALKS 5461-B

Drug: ALKS 5461
Sublingual tablet
Experimental: ALKS 5461 Dose 1

Drug: ALKS 5461
Sublingual tablet
Experimental: ALKS 5461 Dose 2

Drug: ALKS 5461
Sublingual tablet
Experimental: ALKS 5461 Dose 3

Drug: ALKS 5461
Sublingual tablet
Placebo Comparator: Placebo

Drug: Placebo
Sublingual tablet

Outcome Measures

Primary Outcome Measures

  1. Relative bioavailability of ALKS 5461 treatment groups [21 days]

    The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).

Secondary Outcome Measures

  1. Safety and tolerability: Incidence of adverse events [21 days]

Eligibility Criteria

Criteria

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

  • Be in good physical health

  • Body mass index of 18-30 kg/m2

  • Agree to use an approved method of birth control for the duration of the study

  • Additional criteria may apply

Exclusion Criteria:

  • Currently pregnant or breastfeeding

  • History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)

  • Current or history of any clinically significant medical or psychiatric condition

  • Current abuse or dependence on alcohol or any illicit drugs

  • Have used nicotine within 90 days

  • Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days

  • Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days

  • Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study

  • Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)

  • 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: Randall Marshall, MD, Alkermes, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT02068105
Other Study ID Numbers:
  • ALK5461-209
First Posted:
Feb 21, 2014
Last Update Posted:
Apr 21, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Alkermes, Inc.
ALKS 5461
samidorphan

Study Results

No Results Posted as of Apr 21, 2014