Clinical trial NCT02479308: A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
Official title: The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Alkermes
Samidorphan
ALKS 5461
QT/QTc
Buprenorphine
Pharmacodynamics
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
timeFrame: Up to 14 days
Secondary outcomes:
measure: Change in heart rate
timeFrame: Up to 14 days
measure: Incidence of abnormal ECG
timeFrame: Up to 13 days
measure: Tabulation of ECG morphology
timeFrame: Up to 14 days
measure: Correlation of plasma drug levels with QT interval
timeFrame: Up to 14 days
measure: Maximum observed plasma concentration (Cmax) for ALKS 5461
timeFrame: Up to 14 days
measure: Incidence of adverse events (AEs)
timeFrame: Up to 14 weeks
measure: Change in PR interval
timeFrame: Up to 14 days
measure: Change in QRS interval
timeFrame: Up to 14 days
measure: Time to reach the maximum plasma concentration (Tmax) for ALKS 5461
timeFrame: Up to 14 days
measure: AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
timeFrame: Up to 14 days
measure: AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
timeFrame: Up to 14 days
measure: Terminal elimination half-life (T1/2) for ALKS 5461
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
affiliation: Alkermes, Inc.
name: Arielle Stanford, MD
role: STUDY_DIRECTOR
References: