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Trial record 40 of 180 for:    ERYTHROMYCIN

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

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ClinicalTrials.gov Identifier: NCT01338441
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : September 15, 2011
Sponsor:
Collaborators:
Pierre and Marie Curie University
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Ectycell SASU

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiology: RR / QT Drug: Erythromycin Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: 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 Start Date : March 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erythromycin Drug: Erythromycin
4mg/Kg, IV during 20 min once

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Comparison Delta QTcf eryhtromycin-sotalol [ Time Frame: over 3 hours ]
    compare the effect of erythromycin and sotalol on QT prologation

  2. Assess the effect of erythromycin Twave morphologie changes [ Time Frame: 1hour and 20 min ]
    Analysis of Qwave morphologic changes



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338441


Locations
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France
BIOTRIAL
Rueil Malmaison, France, 92500
Sponsors and Collaborators
Ectycell SASU
Pierre and Marie Curie University
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Director: Jean Sebastien Hulot, MD University PMCurrie-INSERM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ectycell SASU
ClinicalTrials.gov Identifier: NCT01338441     History of Changes
Other Study ID Numbers: 2010-022000-41
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011
Keywords provided by Ectycell SASU:
Drug induced QT prolongation
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action