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Completed

NCT Number: NCT02106767

The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CTSI Clinical Research Center, UCSF

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 20mg po x1

Other names: Crestor

Rosuvastatin plus rifampin

Drug

Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1

Other names: Crestor, Rifadin, Rifampicin

Primary outcomes

  1. Area-under-the-concentration curve (AUC) of rosuvastatin

    Time frame: Blood samples collected over a 48 hour period

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of rosuvastatin

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose

  2. Time to concentration maximum (Tmax) of rosuvastatin

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2014
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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