The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

NCT ID: NCT02106767

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-08-07

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 20mg po x1

Rifampin plus rosuvastatin

Group Type: EXPERIMENTAL

Rosuvastatin plus rifampin

Intervention Type: DRUG

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

Interventions

Rosuvastatin

Rosuvastatin 20mg po x1

Intervention Type: DRUG

Rosuvastatin plus rifampin

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

Intervention Type: DRUG

Other Intervention Names

Crestor; Crestor; Rifadin; Rifampicin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Z Benet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Lynda Frassetto, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

CTSI Clinical Research Center, UCSF

San Francisco, California, United States

Countries

United States

Other Identifiers

14-12970

Identifier Type: -

Identifier Source: org_study_id