Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics
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|ClinicalTrials.gov Identifier: NCT01118858|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : July 21, 2017
|Condition or disease|
|Drug Metabolism Phenotype|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||205 participants|
|Official Title:||Exogenous and Endogenous Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Pediatric patients who have a primary diagnosis of ADHD, combined type, hyperactive impulsive, or inattentive type (ADD).
Healthy subjects: Age and gender matched subjects who do not meet any of the exclusion criteria
- Characterize the change in CYP2D6 and CYP3A4 phenotype through adolescence [ Time Frame: Three years ]Growth and development adds an additional level of complexity as the genotype-phenotype relationship may change as children grow and develop. The purpose of this proposal is to characterize the relative roles of ontogeny and genetic variation towards changes in CYP2D6 and CYP3A4 activity during adolescence. Because some drugs commonly used to treat ADHD are metabolized by CYP2D6 and CYP3A4, the information gained from this study will contribute to a better understanding of the dosage requirements of medications used in this patient population.
- Identify endogenous markers of CYP2D6 activity [ Time Frame: Three years ]Metabolomic strategies (HPLC-MS/MS) will be utilized to identify and characterize endogenous compounds that correlate with the formation of dextrorphan (CYP2D6 activity)from the parent compound, dextromethorphan, administered as a phenotyping probe.
Biospecimen Retention: Samples With DNA
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): NCT01118858
|United States, Missouri|
|The Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|United States, Washington|
|The University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Steven Leeder, PharmD, PhD||The Children's Mercy Hospital|