The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Rosuvastatin

Drug: Rosuvastatin plus rifampin

Study type

Interventional

Funder types

Other

Identifiers

NCT02106767

14-12970

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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