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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: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT00994591 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00994591 record still lists
NCT00994591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Pharmacokinetic dosing is the first listed.
NCT00994591 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00994591's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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