HealthyPhase 1NCT01109758
Effects of Fenofibrate on Gene Expression in Healthy Volunteers
A Phase 1 study testing Fenofibrate in people with Healthy, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fenofibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2008to Aug 2008
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female,
- To be aged 40-65 years,
- To be post menopausal female not receiving hormone replacement therapy,
- To have normal homocysteine, folate and vitamin B12 levels at baseline (results available for initiation of treatment),
- To be in good health as determined by medical history, physical examination, ECG, vital signs, serum/urine biochemistry and hematology.
Who cannot join
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, neurologic/psychiatric or emotional, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, (drug) allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the study medication,
- Subjects who have been treated with fenofibrate in a previous study,
- Subjects who have taken a single dose of an investigational drug within 30 days or multiple doses of any investigational drug within 60 days prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fenofibrate on Gene Expression Activity and DNA Methylation Profile in Circulating Monocytes of Healthy Volunteers
The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.
- Conditions
- Healthy
- Being tested
- Fenofibrate
- Keywords
- Fenofibrate, Gene Expression, DNA methylation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
145 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment
The calculation is the difference between the gene expression intensity after 6 weeks of treatment and the gene expression intensity at Baseline
Measured: Between Baseline and 6 weeks
DNA methylation pattern
Measured: 6 weeks
Secondary outcomes (2)
Fenofibric acid levels
Measured: 6 weeks
urinary protein profile
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startMar 2008
- Primary completionJul 2008
- Study completionAug 2008
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109758
- Sponsor's protocol ID
- S282.1.002
- Other IDs
- 2007-006147-52
- Status last verified
- Apr 2010
- First submitted
- 12 Apr 2010
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fenofibrate on Gene Expression Activity and DNA Methylation Profile in Circulating Monocytes of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01109758
- Acronym / sponsor ID
- S282.1.002
- Conditions
- Healthy
- Keywords
- Fenofibrate, Gene Expression, DNA methylation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Apr 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.
The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fenofibrate |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female,
- To be aged 40-65 years,
- To be post menopausal female not receiving hormone replacement therapy,
- To have normal homocysteine, folate and vitamin B12 levels at baseline (results available for initiation of treatment),
- To be in good health as determined by medical history, physical examination, ECG, vital signs, serum/urine biochemistry and hematology.
Key exclusion criteria (3 listed)
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, neurologic/psychiatric or emotional, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, (drug) allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the study medication,
- Subjects who have been treated with fenofibrate in a previous study,
- Subjects who have taken a single dose of an investigational drug within 30 days or multiple doses of any investigational drug within 60 days prior to dosing
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 |
|---|---|---|
| Fenofibrate145 mg | Drug | 1 |
Primary outcome
Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment
Time frame: Between Baseline and 6 weeks
The calculation is the difference between the gene expression intensity after 6 weeks of treatment and the gene expression intensity at Baseline
DNA methylation pattern
Time frame: 6 weeks
2 secondary outcomes
Fenofibric acid levels
Time frame: 6 weeks
urinary protein profile
Time frame: 6 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 23 Apr 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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
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 Fenofibrate in people with Healthy, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
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 3 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 23 Apr 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 United Kingdom. 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?
Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment (time frame: Between Baseline and 6 weeks). The study lists 2 primary outcomes in all. 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 23 Apr 2010.