HealthyPhase 1NCT00692250
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
A Phase 1 study testing Colesevelam hydrochloride film-coated tablets (Cholestagel) in people with Healthy, run by Genzyme, a Sanofi Company at 1 site in Netherlands.
Trial summary
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Colesevelam hydrochloride film-coated tablets (Cholestagel)
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to Dec 2007
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must have a body mass index (BMI) between 19 and 25 inclusive
- Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs.
- Give voluntary written informed consent to participate in the study
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease.
- In addition, history or presence of: Alcoholism or drug abuse within the past year; OR hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; OR Chronic infection
- Subjects who ere tested positive at screening for HIV, HBsAg or HCV
- Subjects who received injectable corticosteroids in the 12 weeks preceding the first dose.
- Subjects who are allergic to castor oil or corn oil
- Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing
Show all 13Show fewer
- Subjects who have used any medications or substances known to be strong inhibitors of CYP3A enzymes within 10 days prior to the first dose.
- Subjects who have used any medications or substances known to be strong inducers of CYP3A enzymes within 28 days prior to the first dose.
- Subjects who have used antibiotics within 14 days prior to the first dose.
- Subjects who have used other medication (including over-the-counter products) vitamins and herbal products within 7 days prior to the first dose.
- Subjects who have used any live attenuated vaccine within 7 days prior to the first dose or are planning to use within 14 days after the end of the study.
- Subjects who, prior to informed consent, would have donated in excess of: 500mL of blood in 14 days;1500mL of blood in 180 days; OR 2500mL of blood in 1 year.
- Subjects who have participated in another clinical trial: within a period less or equal to 2 half live (t1/2) of the previous investigational product used OR within 60 days prior to first dose.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen- Biotech Center
Groningen
About this study
Official title: A Phase I Open Label, Randomised, Single Dose, 2-way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Colesevelam hydrochloride film-coated tablets (Cholestagel)
- Keywords
- Familial Hypercholesterolemia
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colesevelam hydrochloride film-coated tablets (Cholestagel)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
Measured: 12 weeks
Secondary outcomes (2)
Safety
Measured: 12
Tolerability
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692250
- Sponsor's protocol ID
- CHOL00207
- Other IDs
- EudraCT 2007-003724-38
- Status last verified
- May 2015
- First submitted
- 3 Jun 2008
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label, Randomised, Single Dose, 2-way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00692250
- Acronym / sponsor ID
- CHOL00207
- Conditions
- Healthy
- Keywords
- Familial Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Jun 2008 (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.
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject must have a body mass index (BMI) between 19 and 25 inclusive
- Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs.
- Give voluntary written informed consent to participate in the study
Key exclusion criteria (13 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease.
- In addition, history or presence of: Alcoholism or drug abuse within the past year; OR hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; OR Chronic infection
- Subjects who ere tested positive at screening for HIV, HBsAg or HCV
- Subjects who received injectable corticosteroids in the 12 weeks preceding the first dose.
- Subjects who are allergic to castor oil or corn oil
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 |
|---|---|---|
| Colesevelam hydrochloride film-coated tablets (Cholestagel) | Drug | – |
Primary outcome
Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
Time frame: 12 weeks
2 secondary outcomes
Safety
Time frame: 12
Tolerability
Time frame: 12 Weeks
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 5 May 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
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 Colesevelam hydrochloride film-coated tablets (Cholestagel) in people with Healthy, run by Genzyme, a Sanofi Company at 1 site in Netherlands.
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 3 inclusion and 13 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 5 May 2015. 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 Netherlands. 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.
What does the primary outcome measure?
Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
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 5 May 2015.