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

Ectycell

Status and phase

Completed

Phase 1

Conditions

Cardiology: RR / QT

Treatments

Drug: Erythromycin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01338441

2010-022000-41

Details and patient eligibility

About

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 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.

Enrollment

130 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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