Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by University of Utah.
NCT00715988 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00715988 record still lists
NCT00715988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT00715988 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00715988's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia