Clinical trial NCT02106767: The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin
Official title: The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: rosuvastatin
rifampin
pharmacokinetics
drug interaction
healthy volunteer
drug transporter
Asian
White
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Area-under-the-concentration curve (AUC) of rosuvastatin
timeFrame: Blood samples collected over a 48 hour period
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of rosuvastatin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose
measure: Time to concentration maximum (Tmax) of rosuvastatin
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CTSI Clinical Research Center, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Leslie Z Benet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Lynda Frassetto, M.D.
role: PRINCIPAL_INVESTIGATOR
References: