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Drug-Disease Interaction in Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
verapamil
Sponsored by
University of Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Crohn's Disease focused on measuring inflammation, receptor downregulation, reduced response, calcium channels, PK-PD relationship

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alberta Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 14, 2010
Last Updated
December 14, 2010
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01261286
Brief Title
Drug-Disease Interaction in Crohn's Disease
Official Title
Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
inflammation, receptor downregulation, reduced response, calcium channels, PK-PD relationship

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
verapamil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Fedorak, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G-2B7
Country
Canada

12. IPD Sharing Statement

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Drug-Disease Interaction in Crohn's Disease

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