Drug-Disease Interaction in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261286
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 16, 2010
Information provided by:
University of Alberta

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 blocking, in Crohn's disease (CD) patients compared to healthy patients.

Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a surrogate marker of sympathetic nervous activity, will be similar between the healthy patients and the CD patients; the sympathetic nervous system of the heart will be similar to healthy patients; Crohn's disease patients with normal CRP will have higher drug response compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have higher verapamil response than those with similar symptom profiles who are not infliximab treated.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: verapamil Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01261286

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Richard Fedorak, MD University of Alberta

Responsible Party: Dr. Richard Fedorak, University of Alberta Identifier: NCT01261286     History of Changes
Other Study ID Numbers: VER-2010
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: December 16, 2010
Last Verified: December 2010

Keywords provided by University of Alberta:
receptor downregulation
reduced response
calcium channels
PK-PD relationship

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents