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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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