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Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

NCT02062203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-14

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AKB-6548 (therapeutic dose)

Single oral dose of AKB-6548 at a therapeutic dose level

DRUG

AKB-6548 (supratherapeutic dose)

Single oral dose of AKB-6548 at a supratherapeutic dose level

DRUG

Placebo

Single oral dose of placebo

DRUG

Moxifloxacin

Single oral dose of 400 mg moxifloxacin

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Akebia Therapeutics · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-04-30
Completion
2014-04-30

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 NCT02062203 on ClinicalTrials.gov