Measurement of MRP2 Function Using Urinary Coproporphyrins (COVOL)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00746044
First received: September 1, 2008
Last updated: May 14, 2009
Last verified: May 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ABCC2 polymorphisms [ Time Frame: At the time of entering in the study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00746044     History of Changes
Other Study ID Numbers: PHAO07-CLG/COVOL
Study First Received: September 1, 2008
Last Updated: May 14, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Tours:
Healthy

ClinicalTrials.gov processed this record on September 18, 2014