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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Moxifloxacin
* Drug: ALKS 5461
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, Samidorphan, ALKS 5461, QT/QTc, Buprenorphine, Pharmacodynamics