Study of the Ability of Clarithromycin to Induce Oxidative Stress

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Male

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 substance in the urine sample, which is released when the body is exposed to oxidative stress. In addition, there will also be taken blood samples, which is analysed for another substance that is indicative of oxidative stress.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Clarithromycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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