The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin
- Registration Number
- NCT02106767
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rosuvastatin Rosuvastatin - Rifampin plus rosuvastatin Rosuvastatin plus rifampin -
- Primary Outcome Measures
Name Time Method Area-under-the-concentration curve (AUC) of rosuvastatin Blood samples collected over a 48 hour period
- Secondary Outcome Measures
Name Time Method Time to concentration maximum (Tmax) of rosuvastatin 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose Maximum plasma concentration (Cmax) of rosuvastatin 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose
Trial Locations
- Locations (1)
CTSI Clinical Research Center, UCSF
🇺🇸San Francisco, California, United States