N/A
N=25
Rapid Screening Phenotype Test To Evaluate CYP 2C19 Enzyme Activity Using Stable Isotope [13C]Pantoprazole
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00668902 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: DOBmax (Maximum Value of DOB) — 4.44; 3.49; 0.92 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- [13C]Pantoprazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DOBmax (Maximum Value of DOB) |
4.44; 3.49; 0.92 | — |
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 your liver. Exposure to other medications or variations in genes that you have inherited from your parents, may speed up or slow the function of this enzyme. As a result, some patients may develop unwanted effects from a drug while some other patients may not get benefit from taking the same drug. The aim of this study is to determine the function of this enzyme in your liver. We will do this by performing a series of breath tests and blood samples after you take pantoprazole. Pantoprazole is approved as an oral and intravenous drug by the Food and Drug Administration (FDA).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00668902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.