Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 733 for:    warfarin

Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777855
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : July 17, 2013
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: warfarin plus rifampin Drug: warfarin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Rifampin on the Pharmacokinetics of Warfarin in Healthy Volunteers.
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: warfarin then warfarin plus rifampin Drug: warfarin plus rifampin
warfarin 7.5mg po x 1; rifampin 600mg IV x 1

Drug: warfarin
warfarin 7.5mg po x 1




Primary Outcome Measures :
  1. S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours. [ Time Frame: 0-12 hours after warfarin dosing ]
    Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin [ Time Frame: 0-120 hours after warfarin dosing ]
    Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.

  2. Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin [ Time Frame: 0-120 hours after warfarin dosing ]
    Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777855


Locations
Layout table for location information
United States, California
UCSF Medical Center
San Francisco, California, United States, 94112
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Leslie Z Benet, PhD University of California, San Francisco

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00777855     History of Changes
Other Study ID Numbers: warfarin-6006
First Posted: October 22, 2008    Key Record Dates
Results First Posted: July 17, 2013
Last Update Posted: July 17, 2013
Last Verified: May 2013
Keywords provided by University of California, San Francisco:
warfarin
pharmacokinetics
drug transporter
healthy volunteer
drug interaction
rifampin
Additional relevant MeSH terms:
Layout table for MeSH terms
Warfarin
Rifampin
Anticoagulants
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers