A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 129
• 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:

• Have a body mass index (BMI) of 18.0-30.0 kg/m2 at screening
• Is physically healthy
• Agree to abide by the contraception requirements for the duration of the study
• Additional criteria may apply

Exclusion Criteria:

• Have a positive pregnancy test and/or be currently breastfeeding
• Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV)
• Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality
• Have any skin condition likely to interfere with ECG electrode placement or adhesion
• Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine)
• Have used any prescription or over-the-counter (OTC) medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins), or have consumed grapefruit or any grapefruit products within 14 days prior to the first study drug dose
• Have consumed alcohol-, caffeine-, or xanthine-containing products within 24 hours prior to the first study drug dose
• Have used nicotine within 90 days prior to the first study drug dose
• Have used opioids 30 days prior to screening, or have an anticipated need for opioid medication during the study
• Additional criteria may apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo will be matched to Moxifloxacin or ALKS 5461
Experimental: ALKS 5461; Sublingual tablet	Drug: ALKS 5461; Daily administration for a total of 12 dosing days
Active Comparator: Moxifloxacin; Oral tablet	Drug: Moxifloxacin; Single administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate		Up to 14 days
Incidence of abnormal ECG		Up to 13 days
Tabulation of ECG morphology	Findings not present at baseline	Up to 14 days
Correlation of plasma drug levels with QT interval		Up to 14 days
Maximum observed plasma concentration (Cmax) for ALKS 5461		Up to 14 days
Incidence of adverse events (AEs)		Up to 14 weeks
Change in PR interval		Up to 14 days
Change in QRS interval		Up to 14 days
Time to reach the maximum plasma concentration (Tmax) for ALKS 5461		Up to 14 days
AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461		Up to 14 days
AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461		Up to 14 days
Terminal elimination half-life (T1/2) for ALKS 5461		Up to 14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Estimate): November 23, 2015
• Last Update Submitted That Met QC Criteria: November 20, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Alkermes; Pharmacodynamics; Samidorphan; ALKS 5461; Buprenorphine; QT/QTc
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: ALK5461-213