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

NCT02479308 | Completed Phase 1

• 1 other identifier: ALK5461-213
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Alkermes; Samidorphan; ALKS 5461; QT/QTc; Buprenorphine; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

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

  Up to 14 days

Secondary Outcomes (12)

• Change in heart rate

  Up to 14 days

• Incidence of abnormal ECG

  Up to 13 days

• Tabulation of ECG morphology

  Up to 14 days

• Correlation of plasma drug levels with QT interval

  Up to 14 days

• Maximum observed plasma concentration (Cmax) for ALKS 5461

  Up to 14 days

Study Arms (3)

Moxifloxacin

ACTIVE COMPARATOR

Oral tablet

Drug: Moxifloxacin

ALKS 5461

EXPERIMENTAL

Sublingual tablet

Drug: ALKS 5461

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Moxifloxacin DRUG

Single administration

Moxifloxacin

ALKS 5461 DRUG

Daily administration for a total of 12 dosing days

ALKS 5461

Placebo DRUG

Placebo will be matched to Moxifloxacin or ALKS 5461

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

Moxifloxacin; ALKS 5461

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sanjeev Pathak, MD

  Alkermes, Inc.

  STUDY DIRECTOR

• Arielle Stanford, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 23, 2015

Record last verified: 2015-11

Locations

US (1)