HealthyNCT00777855
Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.
A study testing warfarin plus rifampin and warfarin in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- warfarin plus rifampin and warfarin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center
San Francisco, California, 94112
About this study
Official title: The Effects of Rifampin on the Pharmacokinetics of Warfarin in Healthy Volunteers.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarin plus rifampinDrug
warfarin 7.5mg po x 1; rifampin 600mg IV x 1
warfarinDrug
warfarin 7.5mg po x 1
| Study group | Role | What they receive |
|---|---|---|
| warfarin then warfarin plus rifampin | Experimental | Not described Receives: Drug: warfarin plus rifampin; Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.
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.
Measured: 0-12 hours after warfarin dosing
Secondary outcomes (2)
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin
Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
Measured: 0-120 hours after warfarin dosing
Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin
Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
Measured: 0-120 hours after warfarin dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Z Benet, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777855
- Sponsor's protocol ID
- warfarin-6006
- Status last verified
- May 2013
- First submitted
- 20 Oct 2008
- Last updated
- 17 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rifampin on the Pharmacokinetics of Warfarin in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00777855
- Acronym / sponsor ID
- warfarin-6006
- Conditions
- Healthy
- Keywords
- warfarin, pharmacokinetics, drug transporter, healthy volunteer, drug interaction, rifampin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 17 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| warfarin then warfarin plus rifampin | Experimental | Drug: warfarin plus rifampin, Drug: warfarin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warfarin plus rifampinwarfarin 7.5mg po x 1; rifampin 600mg IV x 1 | Drug | warfarin then warfarin plus rifampin |
| warfarinwarfarin 7.5mg po x 1 | Drug | warfarin then warfarin plus rifampin |
Primary outcome
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.
2 secondary outcomes
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
Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin
Time frame: 0-120 hours after warfarin dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Z Benet, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warfarin plus rifampin and warfarin in people with Healthy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.