Drug-Disease Interaction in Crohn's Disease

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G-2B7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verapamil

Drug

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients

Important dates

First posted: Dec 16, 2010
Registry last updated: Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed