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A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers

NCT01514929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2012-05-09

No results posted yet for this study

Summary

The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase in the QT interval.

Conditions

  • Cardiac Effects in Normal Healthy Volunteers

Interventions

DRUG

ACHN-490 Injection

20mg/kg IV 30 minute infusion given once

DRUG

ACHN-490 Injection

15mg/kg IV 30 minute infusion given once

DRUG

Moxifloxacin

400mg oral pill given once

DRUG

Placebo

Placebo oral pill given once

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Achaogen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01514929 on ClinicalTrials.gov