Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out how chemicals in the blood of patients with chronic kidney disease affect how medications are removed from the body. The patient will take one dose of three different drugs, one on each week, for a total of three single doses. The investigators want to find out if these three different medications are affected in different ways by the chemicals in the blood of patients with kidney disease.

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

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Eprosartan; Hydrochlorothiazide; Losartan; Propranolol

Criteria

Inclusion Criteria:

• Male or Female 18-70 years of age.

• Healthy volunteers or chronic kidney disease (GFR<40)

• Be able to provide written informed consent and comply with requirements of the study.

• Avoid eating grapefruit and drinking grapefruit juice from 7 days prior to the first study day until completion of the study.

• Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of the study day.

• Fast from food and beverages at least 8 hours prior to medication dosing.

• Be able to read, speak, and understand English.

Exclusion Criteria:

• Subjects with contraindications to taking the study drugs

• Subjects with known allergies to propranolol, losartan, or eprosartan.

• Subjects who smoke tobacco.

• Subjects with ongoing alcohol or illegal drug use.

• Subjects who are pregnant, lactating, or attempting to conceive.

• Subjects unable to maintain adequate birth control during the study.

• Subjects unable to follow protocol instructions or protocol criteria.

• Subjects with hematocrit < 30mg/dL.

• Subjects who are insulin requiring diabetics.

• Subjects with low, or low normal blood pressure (systolic blood pressure [BP] <100mmHg)

• Subjects with uncontrolled high blood pressure.