Effects of Fenofibrate on Gene Expression in Healthy Volu... | NCT01109758

Studies
Effects of Fenofibrate on Gene Expression in Healthy Volunteers

NCT01109758

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Apr 23, 2010Estimated

Enrollment

26Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Fenofibrate

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-006147-52	EudraCT Number

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Apr 12, 2010

First Submission Date that Met QC Criteria

Apr 22, 2010

First Posted Date

Apr 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2010

Last Update Posted Date

Apr 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: Fenofibrate

Name	Type	Description	Arm Group Labels	Other Names
Fenofibrate	Drug	145 mg	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Between Baseline and 6 weeks
DNA methylation pattern		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fenofibric acid levels		6 weeks
urinary protein profile		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D058607	Fibric Acids
D058610	Isobutyrates
D002087	Butyrates
D000144	Acids, Acyclic