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

Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01338441
Acronym
iQTEST
Enrollment
130
Registered
2011-04-19
Start date
2011-03-31
Completion date
2011-08-31
Last updated
2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiology: RR / QT

Keywords

Drug induced QT prolongation

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.

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

DRUGErythromycin

4mg/Kg, IV during 20 min once

DRUGPlacebo

4mg/Kg, IV during 20 min once

Sponsors

Pierre and Marie Curie University
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Ectycell SASU
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf1hour and 20 minutesDelta 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

MeasureTime frameDescription
Comparison Delta QTcf eryhtromycin-sotalolover 3 hourscompare the effect of erythromycin and sotalol on QT prologation
Assess the effect of erythromycin Twave morphologie changes1hour and 20 minAnalysis of Qwave morphologic changes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026