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NCT01049022 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients

A Phase 1 study of Infections, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target
11
Study locations

NCT01049022 is a Phase 1 study of Infections that has completed, run by Bayer. The registered enrollment target is 31 participants, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT01049022, a Phase 1 study of Infections, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target
11
Study locations

Study Summary

The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children

Conditions Studied

Infections

Interventions

  • DRUG Moxifloxacin (Avelox, BAY12-8039)

Study Locations (11)

Ohio

  • - Cincinnati
  • - Cleveland
  • - Toledo

California

  • - Orange
  • - San Diego

Arkansas

  • - Little Rock

Kentucky

  • - Louisville

Louisiana

  • - New Orleans

Massachusetts

  • - Boston

Missouri

  • - Kansas City

Utah

  • - Salt Lake City

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2010-05
Est. Completion 2013-08
Phase Phase 1

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT01049022

The ClinicalTrials.gov registry entry for NCT01049022 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,406-participant average among 26 other Infections trials with a reported enrollment target (99% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infections appearing as the primary indexed condition, and to 1 intervention - of which Moxifloxacin (Avelox, BAY12-8039) is the first listed.

NCT01049022 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Ohio, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01049022 about?

NCT01049022 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients". The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs ma...

What is the current status of trial NCT01049022?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-05. Estimated completion is 2013-08.

What conditions does trial NCT01049022 study?

This clinical trial studies the following conditions: Infections.

What interventions are being tested in trial NCT01049022?

The interventions under investigation include: Moxifloxacin (Avelox, BAY12-8039) (DRUG).

Who is sponsoring clinical trial NCT01049022?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01049022 being conducted?

This trial has 11 study locations across Arkansas, California, Kentucky, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.