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Trial record 20 of 733 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: warfarin plus rifampin
Drug: warfarin
Enrollment 10
Recruitment Details Healthy non-smoking volunteers from community
Pre-assignment Details All participants were medication free throughout study enrollment
Arm/Group Title Warfarin First, Then Warfarin+Rifampin Warfarin+Rifampin First, Then Warfarin Alone
Hide Arm/Group Description In a randomized, single-dose, two-period, crossover design, 5 participants received warfarin alone 7.5mg po; after a minimum of 14 days, participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po. In a randomized, single-dose, two-period, crossover design, 5 participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po; after a minimum of 14 days, participants received warfarin alone 7.5mg po.
Period Title: First Intervention
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Washout Period (>= 14 Days)
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Second Intervention
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants randomized to receive warfarin alone then warfarin+rifampin, and those randomized to receive warfarin+rifampin then warfarin alone in the crossover design
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
30.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.
Hide Description 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.
Time Frame 0-12 hours after warfarin dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Each of 10 participants received both treatments separated by a minimum of 14 days; treatment sequence was randomly assigned
Arm/Group Title Warfarin Warfarin Plus Rifampin
Hide Arm/Group Description:
warfarin : warfarin 7.5mg po x 1
warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml*h
AUC (0-12 hours) of S-warfarin 2,250  (340) 2,230  (460)
AUC (0-12 hours) of R-warfarin 2,850  (460) 2,930  (510)
2.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin
Hide Description Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
Time Frame 0-120 hours after warfarin dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days
Arm/Group Title Warfarin Warfarin Plus Rifampin
Hide Arm/Group Description:
warfarin : warfarin 7.5mg po x 1
warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml*h
AUC(0-infinity) of S-warfarin 8,420  (1,090) 7,410  (2,500)
AUC(0-infinity) of R-warfarin 18,600  (3,400) 14,100  (4,100)
3.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin
Hide Description Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
Time Frame 0-120 hours after warfarin dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days
Arm/Group Title Warfarin Warfarin Plus Rifampin
Hide Arm/Group Description:
warfarin : warfarin 7.5mg po x 1
warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml
Cmax of S-warfarin 329  (70) 303  (82)
Cmax of R-warfarin 375  (116) 351  (85)
Time Frame 120 hours after warfarin dosing
Adverse Event Reporting Description Each of 10 participants received 2 treatments (warfarin, with or without rifampin), in randomly assigned order, separated by a minimum of 14 days. Participants presented for venous blood collection and were assessed for adverse events at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
 
Arm/Group Title Entire Study Population
Hide Arm/Group Description Each of 10 participants received both study treatments, in randomly assigned sequence, separated by a minimum of 14 days
All-Cause Mortality
Entire Study Population
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Entire Study Population
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Entire Study Population
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leslie Benet
Organization: UCSF
Phone: (415) 476-3853
EMail: leslie.benet@ucsf.edu
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 Submitted: October 20, 2008
First Posted: October 22, 2008
Results First Submitted: January 14, 2013
Results First Posted: July 17, 2013
Last Update Posted: July 17, 2013