Crohn's DiseasePhase 1NCT01261286
Drug-Disease Interaction in Crohn's Disease
A Phase 1 study testing verapamil in people with Crohn's Disease, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- verapamil
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients
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.
- Conditions
- Crohn's Disease
- Being tested
- verapamil
- Keywords
- inflammation, receptor downregulation, reduced response, calcium channels, PK-PD relationship
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verapamilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Richard Fedorak, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261286
- Sponsor's protocol ID
- VER-2010
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT01261286
- Acronym / sponsor ID
- VER-2010
- Conditions
- Crohn's Disease
- Keywords
- inflammation, receptor downregulation, reduced response, calcium channels, PK-PD relationship
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verapamil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Fedorak, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing verapamil in people with Crohn's Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010.