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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02479308

Collaborator

(none)

129

Enrollment

Location

Arms

Duration (Months)

32.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Moxifloxacin

Oral tablet

Drug: Moxifloxacin

Single administration

Experimental: ALKS 5461

Sublingual tablet

Drug: ALKS 5461

Daily administration for a total of 12 dosing days

Placebo Comparator: Placebo

Drug: Placebo

Placebo will be matched to Moxifloxacin or ALKS 5461

Outcome Measures

Primary Outcome Measures

Change in QT interval corrected for heart rate using the Fridericia formula (QTcF) [Up to 14 days]

Secondary Outcome Measures

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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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