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Measurement of MRP2 Function Using Urinary Coproporphyrins (COVOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746044
First Posted: September 3, 2008
Last Update Posted: May 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Tours
  Purpose
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.

Condition
Healthy Subjects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Ratio of Urinary Coproporphyrins I and III as a Potential Biomarker of MRP2 Function in Man

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Urinary coproporphyrins (I/I+III)ratio [ Time Frame: End of three 24-hours periods ]

Secondary Outcome Measures:
  • ABCC2 polymorphisms [ Time Frame: At the time of entering in the study ]

Biospecimen Retention:   Samples With DNA
24h urine DNA

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy volunteers >18y, 20 male, 20 female

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
40 healthy subjects > 18 y 20 male, 20 female
Criteria

Inclusion Criteria:

  • Healthy
  • > 18 y
  • Affiliated to an health insurance

Exclusion Criteria:

  • Patient not able to understand or to comply to the protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746044


Locations
France
CHRU de TOURS
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: Chantal LE GUELLEC CHRU Tours
  More Information

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00746044     History of Changes
Other Study ID Numbers: PHAO07-CLG/COVOL
First Submitted: September 1, 2008
First Posted: September 3, 2008
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by University Hospital, Tours:
Healthy