Status:
COMPLETED
Rapid Screening Phenotype Test To Evaluate CYP 2C19 Enzyme Activity Using Stable Isotope [13C]Pantoprazole
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Sponsor Name Pending
Conditions:
Healthy
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the function of an enzyme that breaks down drugs and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and is located in y...
Detailed Description
The goal of this study is to develop a quick and reliable method that will diagnose hepatic CYP2C19 function and could be used routinely in clinical practice. Specifically, we propose to test pantopra...
Eligibility Criteria
Inclusion
- Asian male or female subjects between 18 and 49 years of age, who are in good physical health with no significant medical problems or laboratory test abnormalities. Subjects should have normal liver and kidney function.
- Subjects with BMI \<30 which will be determined by Metropolitan height and weight tables. Subjects must weigh at least 110 pounds.
- Subjects must agree to refrain from taking any prescription and over-the-counter medications, as well as any herbal medications one week before the start of the study and during the study period.
- Subjects must agree to refrain from consuming alcohol 48 hours before the start of the study and during the study period.
- Subjects must be capable of satisfying protocol requirements and be able to sign written informed consent.
Exclusion
- Subjects who have a history of intolerance or allergy to the study drug: pantoprazole.
- Subjects who have donated blood within the last 60 days of the screening visit or plan to donate blood during the course of the study or within 60 days after study completion.
- Subjects who have had treatment with any investigational drug within the past 30 days.
- Subjects who have used illegal drugs within three months prior to enrollment.
- Female subjects currently taking oral contraceptive birth control pills and who are unwilling or unable to stop oral contraceptives and use a barrier contraceptive method (such as condom, contraceptive foams, etc.) starting from the time of screening phase to the completion of the study.
- Female subjects who are pregnant or lactating.
- Subjects who are unreliable in the opinion of the study physician.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00668902
Start Date
March 1 2007
End Date
January 1 2009
Last Update
December 17 2014
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202