MedTrace Logo

Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples

NCT01338441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2011-09-15

No results posted yet for this study

Summary

The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

Conditions

  • Cardiology: RR / QT

Interventions

DRUG

Erythromycin

4mg/Kg, IV during 20 min once

DRUG

Placebo

4mg/Kg, IV during 20 min once

Sponsors & Collaborators

  • Pierre and Marie Curie University

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Ectycell SASU

    lead INDUSTRY

Principal Investigators

  • Jean Sebastien Hulot, MD · University PMCurrie-INSERM

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • France

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 NCT01338441 on ClinicalTrials.gov