Status:
COMPLETED
Drug-Disease Interaction in Crohn's Disease
Lead Sponsor:
University of Alberta
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type calcium channel block...
Eligibility Criteria
Inclusion
- Willingness to adhere the study protocol
- Males of females of non-childbearing potential aged from 18 to 65 years
- Lab values no more than 10% outside of the lab's stated normal range unless the subject is in the Crohn's disease group and the values are related to the disease, or if the PI decides the abnormality is not clinically significant
- The subject is healthy (except for the Crohn's disease group)
- Non-smoker for at least 3 months
Exclusion
- History of hypersensitivity to verapamil
- Significant history of gastrointestinal (other than Crohn's disease), liver, kidney, or any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Significant history of allergies
- Significant history of cardiovascular or hematological disease
- Significant history of asthma, chronic bronchitis or bronchospastic conditions
- Presence of diabetes mellitus or any other condition which would preclude fasting
- Maintenance therapy with any drug (except those prescribed for Crohn's disease) or a history of drug dependence, alcohol abuse, or serious psychological disease
- Any clinically significant illness other than Crohn's disease in the previous 30 days prior to the study
- Use of enzyme-modifying drugs in the previous 30 days before the study
- Blood donation in the previous 56 days or multiple blood samplings in the previous 30 days before the study
- History of fainting upon blood sampling
- Participation in another clinical trial within 30 days of the study
- Narcotic use
- Glucocorticoid treatment in the last 30 days
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01261286
Last Update
December 16 2010
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2B7