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In Vivo Assessment of Histamine Pharmacodynamics

NCT00809692 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-07

No results posted yet for this study

Summary

A critical first step to address the "pharmacodynamic information gap" in pediatrics resides with the development of methods capable of accurately measuring the time dependent effects of xenobiotic exposure in a manner sufficient to enable an integrative analysis of drug action which incorporates both pharmacokinetic and pharmacogenetic determinants. The proposed study will evaluate laser Doppler flowimetry, a necessary initial step in developing an "ideal" pharmacodynamic surrogate endpoint that ultimately could be used in infants, children and adolescents to fully characterize the impact of development on the pharmacokinetic (PK) / pharmacodynamic (PD) / pharmacogenetic (PG) determinants of drug effect for agents capable of modulating the cellular response to histamine.

Conditions

  • Histamine Biotransformation

Interventions

PROCEDURE

validated techniques for histamine response

the prick test and iontophoresis technique (serial assessment of blood flow using validated Doppler technique)

PROCEDURE

new technique for histamine response

laser Dopper technique and genotyping

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Bridgette L. Jones, MD · Children's Mercy Hospital and Clinics

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-09-30

Countries

  • United States

Study Locations

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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 NCT00809692 on ClinicalTrials.gov