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

Overview

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.

Full Title of Study: “Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2011

Detailed Description

An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.

Interventions

  • Drug: Erythromycin
    • 4mg/Kg, IV during 20 min once
  • Drug: Placebo
    • 4mg/Kg, IV during 20 min once

Arms, Groups and Cohorts

  • Experimental: Erythromycin
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf
    • Time Frame: 1hour and 20 minutes
    • Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups’ erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used.

Secondary Measures

  • Comparison Delta QTcf eryhtromycin-sotalol
    • Time Frame: over 3 hours
    • compare the effect of erythromycin and sotalol on QT prologation
  • Assess the effect of erythromycin Twave morphologie changes
    • Time Frame: 1hour and 20 min
    • Analysis of Qwave morphologic changes

Participating in This Clinical Trial

Inclusion Criteria

  • 18 to 40 years of age
  • Caucasian origin
  • BMI 19 to 29 kg/m²
  • Informed Consent obtained
  • National Health Security Number
  • Eligible for Phase I as mentioned in the national registry of healthy volunteers
  • For woman: use of an effective contraceptive method

Non Inclusion Criteria:

  • Asthma
  • Heart Rate < 50 bpm
  • Hypotension with systolic blood pressure< 100 mm Hg.
  • atrioventricular block (PR interval > 200 ms)
  • Known Chronic illness (hepatic, renal or cardiac impairment, etc..)
  • Raynaud's phenomenon
  • Drug known to prolong QT (http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) in the last 7 days.
  • All chronic treatments are forbidden exceptive : oral contraceptives, paracetamol, vitamins and comfort treatment that do not prolong the QT
  • Known family or individual past history of QT prolongation or unexplained syncope
  • (QTcF) > 450 ms
  • QRS interval non assessable on ECG at rest or bundle-branch block, QRS > 100 ms
  • Allergy to macrolide type antibiotics
  • Known allergy to sotalol or lidocaine
  • Positive blood pregnancy test (Inclusion visit)
  • Known abnormal haemostasis
  • Kaliemia< 3.5 mmol/L
  • Magnesemia< 0,7 mmol/L
  • Under exclusion period or participating to another clinical trial on a new medicinal product
  • Creatinin clearance < 80 ml/min (Cockroft and Gault formula)
  • AST-ALT >3x upper normal limit

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ectycell SASU
  • Collaborator
    • Pierre and Marie Curie University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean Sebastien Hulot, MD, Study Director, University PMCurrie-INSERM

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