At a glance
ClinicalIndex Comparison RecordN/ACompleted· 121 enrolled
Drug / intervention
Genotyping and Phenotyping using dextromethorphan and caffeine as probesprocedure
Likely dose
Dextromethorphan 0.3 mg/kg single dose; caffeine 3.0 mg/kg single doseAI-extracted
Key inclusion· 1
- ✓Healthy children at least 12 months of age at enrollment
Key exclusion· 8
- ✕Height and weight ratio outside 5th to 100th percentile for adjusted age
- ✕Historical or biochemical evidence of hepatic, renal, or hematopoietic dysfunction
- ✕Historical or physical evidence of neurologic disease/condition (excluding simple febrile seizures)
- ✕Historical or physical evidence of swallowing or gastrointestinal dysfunction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Developmental Regulation of CYPs 1A2, 2D6, 3A4
In Brief
An observational study evaluating Genotyping and Phenotyping using dextromethorphan and caffeine as probes for Healthy. Completed, enrolled 121 participants across 1 site.
Detailed Summary
This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Timeline
N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2000
First PostedJul 2005
Primary CompletionJan 2010
TodayJul 2026
First PostedJul 8, 2005
Enrollment StartOct 1, 2000
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 21.0 years ago
Interventions
Genotyping and Phenotyping using dextromethorphan and caffeine as probesprocedure
Single doses of dextromethorphan (0.3 mg/kg)and caffeine (3.0 mg/kg) are administered and urine is collected overnight for measurement of drug and metabolites to determine drug biotransformation activity.