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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Moxifloxacin; Drug: ALKS 5461; Drug: Placebo

• Registration Number: NCT02479308
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin	Oral tablet
ALKS 5461	ALKS 5461	Sublingual tablet
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of plasma drug levels with QT interval	Up to 14 days
Change in heart rate	Up to 14 days
Incidence of abnormal ECG	Up to 13 days
Tabulation of ECG morphology	Up to 14 days	Findings not present at baseline
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

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Overland Park, Kansas, United States