Drug-Disease Interaction in Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01261286
• Date of registration: 14/12/2010
• Prospective Registration: No
• Primary sponsor: University of Alberta
• Public title: Drug-Disease Interaction in Crohn's Disease
• Scientific title: Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients
• Date of first enrolment: August 2010
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01261286
• Study type: Interventional
• Study design: N/A
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Richard Fedorak, MD
• Affiliation: University of Alberta

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: verapamil

Secondary ID(s)

VER-2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors