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Methadone Pharmacokinetics and Cardiac Effects in Newborns

NCT00715988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-06-01

No results posted yet for this 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.

Conditions

Interventions

DRUG

Methadone HCl Inject 10 mg/ml (will require dilution)

Methadone HCl oral solution 5 mg/ml Methadone HCl inject 10 mg/ml (will require dilution)

DRUG

Methadone

Methadone HCl oral solution 5 mg/ml Methadone HCl inject 10 ml/ml (will require dilution) Single dose

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Utah

    lead OTHER

Principal Investigators

  • Robert Ward, M.D. · University of Utah

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Weeks
Max Age
48 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-09-30
Completion
2017-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715988 on ClinicalTrials.gov