The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

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

Details

• Lead Sponsor: Radboud University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pravastatin; Raltegravir Potassium

Criteria

Inclusion Criteria:

• Subject is at least 18 and not older than 55 years of age.

• Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.

• Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.

• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

• Subject is in good age-appropriate health condition.

• Subject has a normal blood pressure and pulse rate.

Exclusion Criteria:

• Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.

• Positive HIV test.

• Positive hepatitis B or C test.

• Pregnant female or breast-feeding female.

• Therapy with any drug.

• Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.

• Fasting triglyceride levels > 8.0 mmol/L

• Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

• History of or current abuse of drugs, alcohol or solvents.

• Inability to understand the nature and extent of the trial and the procedures required.

• Participation in a drug trial within 60 days prior to the first dose.

• Donation of blood within 60 days prior to the first dose.

• Febrile illness within 3 days before the first dose