Status:
COMPLETED
Developmental Regulation of Proteins Responsible for Transforming Drugs in the Body
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy
Eligibility:
All Genders
12-5 years
Brief Summary
This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.
Detailed Description
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 youn...
Eligibility Criteria
Inclusion
- Healthy children 12 months of age at enrollment
Exclusion
- Height and weight ratio outside of the 5th to 100th percentile for adjusted age
- Historical and/or biochemical evidence of hepatic, renal, or hematopoetic dysfunction
- Historical or physical evidence of a neurologic disease/condition (excluding simple, febrile seizures)
- Historical or physical evidence of any disorder associated with swallowing and/or gastrointestinal function
- Concomitant therapy with drugs or other products known to alter the activity of hepatic or intestinal microsomal enzymes(e.g., inducers or inhibitors of CYPs 1A2, 2D6, and/or 3A4), P-glycoprotein or potential competing substrates for the CYPs, under study within 7 days of a scheduled phenotyping evaluation
- Evidence of behavioral, developmental, or psychosocial conditions in the subjects and/or parents/caregivers that, in the opinion of the investigator, would have the potential to adversely impact the level of compliance required for successful study completion
- Evidence of geographic instability (i.e., moving of primary residence within last 24 months) that would adversely influence compliance with repeated study visits necessary for completion of the protocol
- Lack of telephone access required to insure adequate subject contact/follow-up
- Inability to obtain written informed consent from the subject's parents/guardians
Key Trial Info
Start Date :
October 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00117715
Start Date
October 1 2000
End Date
January 1 2010
Last Update
September 12 2017
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108