A Study of ALKS 5461 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: ALKS 5461; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Sublingual tablet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative bioavailability of ALKS 5461 treatment groups	The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability: Incidence of adverse events	21 days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Randall Marshall, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: ALKS 5461; samidorphan
• Other Study ID Numbers: ALK5461-209