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Trial record 20 of 736 for:    warfarin

Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.

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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

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE January 14, 2013
Results First Posted Date  ICMJE July 17, 2013
Last Update Posted Date July 17, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Pharmacokinetics of warfarin dosed with and without rifampin. [ Time Frame: Day 1 ]
Change History Complete list of historical versions of study NCT00777855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.
Official Title  ICMJE The Effects of Rifampin on the Pharmacokinetics of Warfarin in Healthy Volunteers.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: warfarin plus rifampin
    warfarin 7.5mg po x 1; rifampin 600mg IV x 1
  • Drug: warfarin
    warfarin 7.5mg po x 1
Study Arms  ICMJE Experimental: warfarin then warfarin plus rifampin
Interventions:
  • Drug: warfarin plus rifampin
  • Drug: warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777855
Other Study ID Numbers  ICMJE warfarin-6006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leslie Z Benet, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP