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Exogenous and Endogenous Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics

This study is currently Recruiting

May 2010 By Children's Mercy Hospital Kansas City

First Recieved on May 6, 2010

Last Updated on May 6, 2010

Sponsor: Children's Mercy Hospital Kansas City
Collaborators: National Institutes of Health (NIH)
Information provided by: Children's Mercy Hospital Kansas City
Identifier: NCT01118858

Purpose

Cytochrome P450 2D6 (CYP2D6) is an important enzyme in the body for breaking down many medications that are commonly used in children of various ages. The purpose of this proposal is to investigate the relative roles of development and genetic variation in CYP2D6 activity in school-aged children and adolescents with attention deficit and hyperactivity disorder and health controls using the over-the-counter cough suppressant, dextromethorphan or "DM", a standard probe for determining CYP2D6 phenotype. Embedded in the study design are sub-studies to search for by-products of normal body metabolism that reflect differences in enzyme activity, and a pharmacokinetic study to assess the consequences of CYP2D6 genetic variation on the systemic exposure to medications used by this patient population. Ultimately, the goal of the research is to personalize the use of medications in children by selecting the appropriate dose of the correct medication for individual patients.

Study Type: Observational
Study Design: Observational Model: Case Control, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:7 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - Males and females between 7 and 15 years of age. Exclusion Criteria: - Inability to have blood drawn for the screening lab tests - Current therapy with medications metabolized by or known to inhibit CYP2D6: *fluoxetine (Prozac?) - sertraline (Zoloft?) - paroxetine (Paxil?) - venlafaxine (Effexor?) - risperidone (Risperdal ?) - imipramine - nortriptyline - desipramine - amitriptyline - fenfluramine - terbinafine - loratadine (Claritin?) - cyclobenzaprine - haloperidol (Haldol?) - metoprolol - quinidine - propafenone (Rythmol?) - cimetidine (Tagamet?) - tamoxifen - over-the-counter diphenhydramine-containing drugs - including Benadryl and generics and the cough and cold preparations Allegra? - Dytuss? - Tusstat? - Robitussin? - pro-drugs codeine - tramadol - hydrocodone - oxycodone (Percodan?, Percocet?) that are converted by 2D6 into their active forms. - Illicit drug use, treatment within the past 2 months with paroxetine or fluoxetine, or the past six months with terbinafine are also exclusion criteria. - Inability or unwillingness to fast 2 hours prior to the study session - Existence of diagnosis which may influence absorption and gastric emptying; such as reflux , inflammatory bowel disease, or Crohn's disease. - A demonstrated adverse reaction to previous dextromethorphan exposure - Impaired hepatic or renal activity, or physical examination as determined by the Sub Investigator's discretion. - Pregnancy - Body-mass index (BMI) <5th and >95th percentile

Investigators

  • Investigator: Steven Leeder, PharmD, PhD - Principal Investigator - The Children's Mercy Hospital

Locations

  • The Children's Mercy Hospital

    Kansas City, Missouri 64108 United States

  • The University of Washington

    Seattle, Washington 98195 United States

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