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NCT02358499 · ClinicalTrials.gov registry record · Phase 1

Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children

A Phase 1 study of Fungal Infections, sponsored by Children's Mercy Hospital Kansas City.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target
1
Study location

NCT02358499: Completed Phase 1 study of Fungal Infections, sponsored by Children's Mercy Hospital Kansas City.

NCT02358499 is a Phase 1 study of Fungal Infections that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 31 participants, below the 320-participant average among 3 other Fungal Infections trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02358499, a Phase 1 study of Fungal Infections, has completed, sponsored by Children's Mercy Hospital Kansas City.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

The main goal of this study is to see how the body breaks down an antifungal drug named posaconazole in children with certain cancers, blood disorders, or transplantation of bone marrow or similar blood cells. This study will also help us learn whether a child's age, genetics, or disease affect how well the body breaks down posaconazole.

Primary Outcome

Posaconazole concentrations in the plasma will be measured after a single dose of posaconazole injection to estimate the area under the concentration-versus-time curve (AUC). Blood samples for the assessment of AUC will be collected predose on Day 1 and then at specified time points up to 96 hours postdose.

Conditions Studied

Interventions

  • DRUG Posaconazole

Study Locations (1)

Missouri

  • Children's Mercy Hospital Kansas City - Kansas City

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2015-01
Est. Completion 2018-12-31
Phase Phase 1

What the finished NCT02358499 record still lists

NCT02358499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 320-participant average among 3 other Fungal Infections trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Fungal Infections appearing as the primary indexed condition, and to 1 intervention - of which Posaconazole is the first listed.

NCT02358499 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT02358499 about?

NCT02358499 is a clinical study titled "Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children". The main goal of this study is to see how the body breaks down an antifungal drug named posaconazole in children with certain cancers, blood disorders, or transplantation of bone marrow or similar blood cells. This study will also help us learn whether a child's age, genetics, or disease affect how ...

What is the current status of trial NCT02358499?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2015-01. Estimated completion is 2018-12-31.

What conditions does trial NCT02358499 study?

This clinical trial studies the following conditions: Fungal Infections.

What interventions are being tested in trial NCT02358499?

The interventions under investigation include: Posaconazole (DRUG).

Who is sponsoring clinical trial NCT02358499?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02358499 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02358499, the US trial registry maintained by the National Library of Medicine. NCT02358499 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.