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NCT00715988 · ClinicalTrials.gov registry record · Phase 1
Methadone Pharmacokinetics and Cardiac Effects in Newborns
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00715988 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 7 participants.
The verdict
NCT00715988, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The Primary objectives of this proposal are to determine the population kinetics for methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post menstrual age (PMA) who are 1 week old and older and establish any correlations of the kinetics with PMA to determine the bioavailability for enterally administered methadone in these newborns and young infants. The secondary objectives of this proposal are to explore possible genotypic changes in CYP3A4-3A7-3A5, CYP2B6, CYP2C8, CYP2C19, and CYP2D6 and PGO on the kinetics of methadone in neonates and young infants and to test the safety of methadone in this population by correlating the plasma concentrations of the methadone enantiomers, S-methadone and R-methadone, with changes in cardiac repolarization by measurement of corrected QT, heart rate, and blood pressure.
Interventions
- DRUG Methadone
- DRUG Methadone HCl Inject 10 mg/ml (will require dilution)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2007-10 |
| Est. Completion | 2017-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00715988
The ClinicalTrials.gov registry entry for NCT00715988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT00715988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00715988 about?
NCT00715988 is a clinical study titled "Methadone Pharmacokinetics and Cardiac Effects in Newborns". The Primary objectives of this proposal are to determine the population kinetics for methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post menstrual age (PMA) who are 1 week old and older and establish any correlations of the kinetics with PMA to determine the bi...
What is the current status of trial NCT00715988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2007-10. Estimated completion is 2017-02-10.
What interventions are being tested in trial NCT00715988?
The interventions under investigation include: Methadone (DRUG), Methadone HCl Inject 10 mg/ml (will require dilution) (DRUG).
Who is sponsoring clinical trial NCT00715988?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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