Developmental Regulation of Proteins Responsible for Transforming Drugs in the Body
Completed
Conditions studied: Healthy
In brief
This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.
Key facts
- Study ID
- NCT00117715
- Run by
- Children's Mercy Hospital Kansas City
- People needed
- 121
- Starts
- 2000-10-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2017-09-12
Who can join
Age: 1 and older, up to 5. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy children 12 months of age at enrollment
You may not qualify if…
- 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
Where it is running
- Children's Mercy Hospital — Kansas City, Missouri, 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.