The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02106767

Collaborator

(none)

Enrollment

Location

Arms

21.2

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Rosuvastatin Drug: Rosuvastatin plus rifampin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Aug 7, 2016

Actual Study Completion Date :

Aug 7, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosuvastatin	Drug: Rosuvastatin Rosuvastatin 20mg po x1 Other Names: Crestor
Experimental: Rifampin plus rosuvastatin	Drug: Rosuvastatin plus rifampin Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1 Other Names: Crestor Rifadin Rifampicin

Arm

Intervention/Treatment

Active Comparator: Rosuvastatin

Drug: Rosuvastatin

Rosuvastatin 20mg po x1

Other Names:

Crestor

Experimental: Rifampin plus rosuvastatin

Drug: Rosuvastatin plus rifampin

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

Other Names:

Crestor

Rifadin

Rifampicin

Outcome Measures

Primary Outcome Measures

Area-under-the-concentration curve (AUC) of rosuvastatin [Blood samples collected over a 48 hour period]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTSI Clinical Research Center, UCSF	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Leslie Z Benet, PhD, University of California, San Francisco
Principal Investigator: Lynda Frassetto, M.D., University of California, San Francisco