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

NCT02479308 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2015-11-23

No results posted yet for this study

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

Interventions

DRUG

Moxifloxacin

Single administration

DRUG

ALKS 5461

Daily administration for a total of 12 dosing days

DRUG

Placebo

Placebo will be matched to Moxifloxacin or ALKS 5461

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjeev Pathak, MD · Alkermes, Inc.

  • Arielle Stanford, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02479308 on ClinicalTrials.gov