iQTEST: Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf [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
- Comparison Delta QTcf eryhtromycin-sotalol [over 3 hours]
compare the effect of erythromycin and sotalol on QT prologation
- Assess the effect of erythromycin Twave morphologie changes [1hour and 20 min]
Analysis of Qwave morphologic changes
Eligibility Criteria
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.
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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
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(QTcF) > 450 ms
-
QRS interval non assessable on ECG at rest or bundle-branch block, QRS > 100 ms
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Allergy to macrolide type antibiotics
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Known allergy to sotalol or lidocaine
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Study Director: Jean Sebastien Hulot, MD, University PMCurrie-INSERM
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-022000-41