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NCT00746044 Clinical Trial

Measurement of MRP2 Function Using Urinary Coproporphyrins

Healthy Subjects Clinical Trial

— COVOL  

Official title:
Evaluation of the Ratio of Urinary Coproporphyrins I and III as a Potential Biomarker of MRP2 Function in Man

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00746044
Other study ID # PHAO07-CLG/COVOL
Secondary ID
Status Completed
Phase N/A
First received September 1, 2008
Last updated May 14, 2009
Start date February 2008
Est. completion date April 2009

Study information
Verified date May 2009
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be increased in patients with mutations in MRP2/ABCC2 gene.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2009
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Healthy

- > 18 y

- Affiliated to an health insurance

Exclusion Criteria:

- Patient not able to understand or to comply to the protocol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de TOURS Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urinary coproporphyrins (I/I+III)ratio End of three 24-hours periods No
Secondary ABCC2 polymorphisms At the time of entering in the study No
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