Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics

Completed

Conditions studied: Drug Metabolism Phenotype

In brief

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.

Key facts

Study ID

NCT01118858

Run by

Children's Mercy Hospital Kansas City

People needed

205

Starts

2010-04-01

Expected to finish

2015-10-01

Last updated by the study team

2017-07-21

Who can join

Age: 7 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females between 7 and 15 years of age.

You may not qualify if…

• Inability to have blood drawn for the screening lab tests
• Current therapy with medications known to inhibit CYP2D6: *fluoxetine (Prozac®)
• sertraline (Zoloft®)
• paroxetine (Paxil®)
• venlafaxine (Effexor®)
• imipramine
• nortriptyline
• desipramine
• amitriptyline
• fenfluramine
• terbinafine
• 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
• Dytuss®
• Tusstat®
• Robitussin®
• pro-drugs codeine
• tramadol

Where it is running

• The Children's Mercy Hospital — Kansas City, Missouri, United States
• The University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.