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Completed

NCT Number: NCT02479308

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin

Drug

Single administration

ALKS 5461

Drug

Daily administration for a total of 12 dosing days

Placebo

Drug

Placebo will be matched to Moxifloxacin or ALKS 5461

Primary outcomes

  1. Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)

    Time frame: Up to 14 days

Secondary outcomes

  1. Change in heart rate

    Time frame: Up to 14 days

  2. Incidence of abnormal ECG

    Time frame: Up to 13 days

  3. Tabulation of ECG morphology

    Time frame: Up to 14 days

    Findings not present at baseline

  4. Correlation of plasma drug levels with QT interval

    Time frame: Up to 14 days

  5. Maximum observed plasma concentration (Cmax) for ALKS 5461

    Time frame: Up to 14 days

  6. Incidence of adverse events (AEs)

    Time frame: Up to 14 weeks

  7. Change in PR interval

    Time frame: Up to 14 days

  8. Change in QRS interval

    Time frame: Up to 14 days

  9. Time to reach the maximum plasma concentration (Tmax) for ALKS 5461

    Time frame: Up to 14 days

  10. AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461

    Time frame: Up to 14 days

  11. AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461

    Time frame: Up to 14 days

  12. Terminal elimination half-life (T1/2) for ALKS 5461

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2015
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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