The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

• Status: Completed
• Trial end date: 2016-08-07
• Target enrollment: 0
• Participant gender: All

Summary

The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.

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

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Rifampin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Healthy Asian volunteers of Han-Chinese/Japanese/Korean descent whose parents and grandparents are Han-Chinese/ Japanese/ Korean.

• Healthy Caucasian volunteers of White/Caucasian/European-born descent whose parents and grandparents are White/Caucasian/European.

• Male or female, ages 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam, and laboratory evaluations.

• Subjects who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.

• Subjects with the following genotype: SLCO1B1*1a and ABCG2 421CC.

• Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use.

• Subjects able to abstain from grapefruit, grapefruit juice, oranges, orange juice, caffeinated beverages and/or alcoholic beverages from 7am the day before the study to completion of that study day.

• Participants determined to have normal liver and kidney function as measured at baseline

• BMI between 18.0 - 30 kg/m2

• Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing.

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

• Subjects capable of providing informed consent and completing the requirements of the study.

Exclusion Criteria:

• Subjects with active medical problems

• Subjects on chronic prescription or OTC medication that cannot be stopped 2 weeks prior to and during the study.

• Subjects incapable of multiple blood draws (HCT < 30mg/dL)

• Subjects with a history of rhabdomyolysis

• Subjects with a history of drug-related myalgias

• Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias

• Subjects with a history of GI bleed or peptic ulcer disease

• Subjects who smoke tobacco or have ongoing alcohol or illegal drug use

• Subjects who are pregnant, lactating, or trying to conceive during the study period

• Subjects allergic to rosuvastatin or rifampin or any known component of the medications

• Anyone who in the opinion of the study investigators is unable to do the study