Status:
UNKNOWN
Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on hea...
Eligibility Criteria
Inclusion
- Healthy male.
- age between 18 and 45.
- BMI between 19 and 25 kg/m2
- Normal physical exam.
- Blood analysis without relevant findings.
- Negative serology for hepatitis B, Hepatitis C and HIV.
- Negative urine test for abuse drugs.
Exclusion
- Severe psychiatric disease.
- Dyslipemia.
- Alcohol intake above 30 g per day.
- Smokers
- Xanthine intake above 5 coffee cup -equivalents per day
- Use of any drugs in the last month
- Participation in other trials in the last 3 months
- Diseases capable to modify drug ADME
- Drug allergy
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00772720
Start Date
March 1 2010
End Date
March 1 2011
Last Update
March 31 2010
Active Locations (1)
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1
Hospital Clinic
Barcelona, Catalonia, Spain, 08036