MedTrace Logo

Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose

NCT01327066 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-03-07

No results posted yet for this study

Summary

The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin in healthy male and female subjects.

Conditions

  • QTc Interval

Interventions

DRUG

Droxidopa

600 mg, single oral dose

DRUG

Droxidopa

2000 mg, single oral dose

DRUG

Moxifloxacin

400 mg, single oral dose

DRUG

Placebo

Placebo matching Droxidopa or Moxifloxacin

Sponsors & Collaborators

  • Chelsea Therapeutics

    lead INDUSTRY

Principal Investigators

  • Thomas Hunt, MD · PPD Phase I Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-04-30
Completion
2011-06-30

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 NCT01327066 on ClinicalTrials.gov