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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00117715 |
This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.
Condition | Intervention |
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Healthy |
Procedure: Genotyping and Phenotyping |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Random Sample, Prospective Study |
Official Title: | Developmental Regulation of CYPs 1A2, 2D6, 3A4 |
Estimated Enrollment: | 150 |
Study Start Date: | October 2000 |
For many years, it has been considered dogma that drug biotransformation capability is limited at best in the fetus and newborn but increases over the first year of life to levels in toddlers and young children that generally exceed adult capacity. There are several situations where examination of clinical PK data has revealed discernable patterns of drug clearance that can be attributed to developmental differences in drug biotransformation. It has become apparent that there are developmental differences in expression among drug metabolizing enzyme families (cytochromes P450 or "CYPs", etc.) Furthermore, individual drug metabolizing enzymes with in a family may have unique developmental profiles that influence the therapeutic response, desired or undesired, to a given agent.
All subjects will have a single 5 ml venous blood sample taken upon admission to the study. All subjects will be given a single oral dose of caffeine and dextromethorphan. Patients will be allowed to consume their normal age appropriate diet around the time of study drug administration and through the sample collection periods. All spontaneously voided urine will be collected for a period of 12 hours following the caffeine and dextromethorphan administration
The specific aim of this proposal is to extend the current longitudinal investigation into the preschool age group (1 to 5 years of age). The developmental profile of CYPs, 1A2, 2D6, and 3A4 will be determined by caffeine and dextromethorphan phenotyping procedures. The purpose of this study is to determine the age/developmental stage at which the CYP2 1A2, 2D6 and 3A4 activities exceed adult activities.
Ages Eligible for Study: | 12 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | J. Steven Leeder, Pharm. D, Ph.D. | Children's Mercy Hospital, Kansas City, MO |
Study ID Numbers: | PPRU 10390 |
Study First Received: | July 6, 2005 |
Last Updated: | June 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00117715 |
Health Authority: | United States: Federal Government |
Developmental regulation of CYPs 1A2, 2D6, 3A4 Ontogeny pharmacokinetics drug biotransformation enzymatic biotransformation of drugs |
Healthy |