Status:
COMPLETED
Study of the Ability of Clarithromycin to Induce Oxidative Stress
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Oxidative Stress
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to examine whether Klacid® (Clarithromycin) will induce oxidative stress (stress from oxygen) in healthy subjects. This is done by measuring the content of a particular sub...
Detailed Description
The purpose of the study is to examine whether Klacid® induce oxidative stress in healthy subjects. Many studies have shown that atherosclerosis can cause acute myocardial infarction (AMI). The devel...
Eligibility Criteria
Inclusion
- Caucasian
- Non-smoker
- Body mass index (BMI) must be ≥18 and ≤ 30
- Blood pressure must be within the following limits:
- Systolic blood pressure (110 mmHg \> X \< 140 mmHg)
- Diastolic blood pressure (60 mmHg \> Y \< 90 mmHg)
- Normal lipid plasma levels:
- Total cholesterol (≤ 6,0 mmol/l)
- HDL-cholesterol (≥ 0,9 mmol/l)
- LDL-cholesterol (≤ 4,5 mmol/l)
- Triglycerides (0,5-2,2 mmol/l)
Exclusion
- Smokers
- CRP: \> 10 mg/l
- Prolonged QT interval (defined as QTc \> 450 msec.)
- Severe renal insufficiency (Cpl (creatinine) \> 0100 mmol/l)
- Hereditary galactose intolerance
- A special form of hereditary lactase deficiency (Lapp Lactase deficiency)
- Glucose/galactose malabsorption
- Use of medicines and herbal remedies that affect/is affected by Clarithromycin, or lead to QT prolongation, for example, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine, fluconazole, ritonavir, carbamazepine, kinidin, disopyramide, lovastatin, simvastatin, warfarin, acenocoumarol, sildenafil, Tadalafil, vardenafil, theophylline, tolterodine, triazolo benzodiazepins, omeprazole, colchinine, digoxin, zidovudine, phenytoin, valproat, atazanavir, itraconazole, saquinavir
- Inborn condition with prolonged QT interval
- The following disorders:
- Coronary artery disease
- Former cardiac arrhythmias
- Severe heart insufficiency
- Non-compensated hypokalemia (defined as Cpl (K) \< 3.2 mmol/ l) and/or hypomagnesemia (defined as Cpl (Mg) \< 0.67 mmol/l)
- Bradycardia ( \< 50 bpm)
- Known allergy to clarithromycin or other macrolides
- Narcotic
- Eating food supplements
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00707330
Start Date
May 1 2008
End Date
July 1 2008
Last Update
August 11 2008
Active Locations (1)
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1
Department of Clinical Pharmacology Q, Rigshospitalet, Blegdamsvej 9
Kopenhagen O, Denmark, 2100