Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.

NCT ID: NCT00777855

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-03-31

Brief Summary

The purpose of this study is to determine the importance of uptake drug transporters in the drug disposition of warfarin. We predict that the elimination of warfarin will be decreased when co-dosed with an inhibitor of uptake drug transporters.

Conditions

Healthy

Study Design

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

Study Groups

warfarin then warfarin plus rifampin

Group Type: EXPERIMENTAL

warfarin plus rifampin

Intervention Type: DRUG

warfarin 7.5mg po x 1; rifampin 600mg IV x 1

warfarin

Intervention Type: DRUG

warfarin 7.5mg po x 1

Interventions

warfarin plus rifampin

warfarin 7.5mg po x 1; rifampin 600mg IV x 1

Intervention Type: DRUG

warfarin

warfarin 7.5mg po x 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female 18-60 years of age;
• Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations;
• BMI between 18.5 - 30 kg/m2;
• Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen);
• Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use;
• Be able to provide written informed consent and comply with requirements of the study;
• Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
• Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
• Avoidance of contact sports and/or other activities with significant risk of trauma injury for 7 days after each study day.
• Fast from food and beverages at least 8 hours prior to medication dosing;
• Be able to read, speak and understand English

Exclusion Criteria

• Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
• Subjects with known allergy to warfarin and/or rifampin;
• Subjects who are not homozygous for cytochrome P450 2C9 (CYP2C9 *1) (known poor metabolizers).
• Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias;
• Subjects with liver failure or liver function test (LFT) results >2x upper limit of normal;
• Subjects with clinically significant elevations in international normalized ratio (INR), prothrombin (PT), prothrombin time (PTT), serum creatinine (SCr), blood urea nitrogen (BUN) or other screening laboratory tests as determined by study physician;
• Subjects with Hct <30 mg/dL;
• Subjects with history of GI bleed or peptic ulcer disease;
• Subjects with a recent history of trauma;
• Subjects with a recent history of or upcoming plan of surgery;
• Subjects who smoke tobacco;
• Subjects with ongoing alcohol or illegal drug use;
• Subjects who are pregnant, lactating or attempting to conceive;
• Subjects unable to maintain adequate birth control during the study;
• Subjects unable to follow protocol instructions or protocol criteria.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 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

Locations

UCSF Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

warfarin-6006

Identifier Type: -

Identifier Source: org_study_id