The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rosuvastatin; Drug: Rosuvastatin plus rifampin

• 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

Study Timeline

• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Study Start: 2014-11
• Primary Completion: 2016-08-07
• Study Completion: 2016-08-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

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
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
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

Trial Locations

Locations (1)

CTSI Clinical Research Center, UCSF; 🇺🇸 San Francisco, California, United States