N/A
N=121
Developmental Regulation of Proteins Responsible for Transforming Drugs in the Body
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00117715 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Change in CYP2D6 Drug Metabolism Phenotype With Age — -1.974; -2.083; -2.162; -2.073 unitless ratio — p=0.035
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Genotyping and Phenotyping using dextromethorphan and caffeine as probes (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in CYP2D6 Drug Metabolism Phenotype With Age |
-1.974; -2.083; -2.162; -2.073; -2.161; -2.185 | 0.035 sig |
| PRIMARY Change in CYP3A4 Drug Metabolism Phenotype With Age |
-0.069; -0.117; -0.142; -0.158; -0.109; -0.136 | 0.194 |
| PRIMARY Change in CYP1A2 Drug Metabolism Phenotype With Age |
-0.851; -0.823; -0.858; -0.856; -0.832; -0.853 | 0.831 |
Summary
This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.
Eligibility Criteria
Inclusion Criteria
- Healthy children 12 months of age at enrollment
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00117715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.