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NCT00994591 · ClinicalTrials.gov registry record · Phase 1
Cotinine Metabolism in Infants and Children
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00994591 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 56 participants.
The verdict
NCT00994591, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and small children than adults. This pharmacokinetic study is designed to determine whether children metabolize cotinine differently than adults. Seventy-two healthy children between the ages of 2 months and 6 years will come with their mothers to SFGH GCRC for one approximately 9 hour visit. After being examined by a pediatrician, the child will be administered one dose of cotinine at .05 mg/kg. Saliva and urine samples will be collected prior to dosing and throughout the day to characterize the metabolism and excretion of cotinine. The investigators have previously shown that a ratio of 3'-hydroxycotinine/cotinine (3HC/Cot) in saliva correlates closely to nicotine metabolism. Following these one day hospital visits, a research assistant will visit the participants in their homes to collect urine and saliva samples at 1,2,3,7, and 10 days after the initial dose.
Interventions
- DRUG Pharmacokinetic dosing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00994591
The ClinicalTrials.gov registry entry for NCT00994591 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pharmacokinetic dosing is the first listed.
NCT00994591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00994591 about?
NCT00994591 is a clinical study titled "Cotinine Metabolism in Infants and Children". Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and small children than adults. This pharmacokinetic study is designed to determine whether children metabolize cotinine differently than adults. Seventy-two healthy children between the ages of 2 months and 6 yea...
What is the current status of trial NCT00994591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2007-01. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00994591?
The interventions under investigation include: Pharmacokinetic dosing (DRUG).
Who is sponsoring clinical trial NCT00994591?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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