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

Information source: Ectycell SASU
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiology: RR / QT

Intervention: Erythromycin (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Ectycell SASU

Official(s) and/or principal investigator(s):
Jean Sebastien Hulot, MD, Study Director, Affiliation: University PMCurrie-INSERM


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf

Secondary outcome:

Comparison Delta QTcf eryhtromycin-sotalol

Assess the effect of erythromycin Twave morphologie changes

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.


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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


- Creatinin clearance < 80 ml/min (Cockroft and Gault formula)

- AST-ALT >3x upper normal limit

Locations and Contacts

BIOTRIAL, Rueil Malmaison 92500, France
Additional Information

Starting date: March 2011
Last updated: September 14, 2011

Page last updated: August 23, 2015

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