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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ALKS 5461; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02479308

ALK5461-213

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups, including a placebo group

Moxifloxacin

Active Comparator group

Description:

Oral tablet

Treatment:

Drug: Moxifloxacin

ALKS 5461

Experimental group

Description:

Sublingual tablet

Treatment:

Drug: ALKS 5461

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo