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Summary

for people ages 18–65 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:

Description

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.

Official Title

The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers

Keywords

Healthy rosuvastatin rifampin pharmacokinetics drug interaction healthy volunteer drug transporter Asian White Rosuvastatin Calcium

Eligibility

You can join if…

Open to people ages 18–65

  • 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.

You CAN'T join if...

  • 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

Location

  • CTSI Clinical Research Center, UCSF
    San Francisco, California, 94143, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02106767
Phase
Phase 1
Lead Scientists
Leslie Z Benet
Lynda Frassetto
Study Type
Interventional
Last Updated
December 2015