NCT00746044

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

2 months

First QC Date

September 1, 2008

Last Update Submit

May 14, 2009

Conditions

Healthy Subjects

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Urinary coproporphyrins (I/I+III)ratio

    End of three 24-hours periods

Secondary Outcomes (1)

  • ABCC2 polymorphisms

    At the time of entering in the study

Study Arms (1)

1

Healthy volunteers \>18y, 20 male, 20 female

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 healthy subjects \> 18 y 20 male, 20 female

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de TOURS

Tours, 37000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

24h urine DNA

Study Officials

  • Chantal LE GUELLEC

    CHRU TOURS

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

FR(1)