Overview

This trial is active, not recruiting.

Condition healthy
Treatments rosuvastatin, rosuvastatin plus rifampin
Phase phase 1
Sponsor University of California, San Francisco
Start date November 2014
End date August 2015
Trial size 16 participants
Trial identifier NCT02106767, 14-12970

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Arm
(Active Comparator)
rosuvastatin Crestor
Rosuvastatin 20mg po x1
(Experimental)
rosuvastatin plus rifampin Crestor
Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1

Primary Outcomes

Measure
Area-under-the-concentration curve (AUC) of rosuvastatin
time frame: Blood samples collected over a 48 hour period

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers
Principal investigator Leslie Z Benet, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.