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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Moxifloxacin (Avelox, BAY12-8039) (Drug); Moxifloxacin (Avelox, BAY12-8039) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area under the Concentration-Time Curve (AUC) of Moxifloxacin and its Metabolites

Maximum Observed Drug Concentration in Plasma (Cmax) of Moxifloxacin and its Metabolites

Number of Subjects With Treatment Emergent Findings on Joint Assessment: Baseline

Number of Subjects With Treatment Emergent Findings on Joint Assessment : At any Time During Treatment

Secondary outcome:

Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin and its Metabolites

Half Life Associated With Terminal Slope (t1/2) of Moxifloxacin and its Metabolites

Total Amount Excreted in the Urine (Aeur) of Moxifloxacin and its Metabolites

Volume of Distribution at Steady State (Vss) of Moxifloxacin and its Metabolites

Plasma Clearance (CL) of Moxifloxacin and its Metabolites

Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kilogram Body Weight (AUCnorm) of Moxifloxacin and its Metabolites

Maximum Observed Plasma Concentration Divided by Dose Per kilogram Body Weight (Cmax,Norm) of Moxifloxacin and its Metabolites

Eligibility

Minimum age: 3 Months. Maximum age: 14 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females, ages 3 months through 14 years inclusive

- Receiving antibiotics for suspected or proven infection

Exclusion Criteria:

- Body weight greater than 45 kg

- Patients taking anti-seizure medications within 30 days of moxifloxacin dosing

- Known or suspected allergy to quinolones

- History of tendon disease/disorder related to quinolone treatment

- Severe, life-threatening disease with a life expectancy of less than 48 hours and/or

known rapidly fatal underlying disease (death expected within 2 months)

- Abnormal musculoskeletal evaluation at baseline assessment; or chronic

musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)

- Cardiac arrhythmia

- Evidence of renal or hepatic disease, based on laboratory findings (serum creatinine,

total bilirubin, or ALT, > 1. 5 times upper limit of normal) and physical exam

- Patients receiving Class IA (e. g., quinidine, procainamide) or Class III (e. g.,

amiodarone, sotalol) antiarrhythmic agents

- Patients taking any medication known to increase the QT interval, eg, amiodarone,

astemizole, bepridil, chloroquine, chlorpromazine, cisapride, disopyuramide, dofetilide, droperidol, halofantrine, haloperidol, ibutilide, levomethadyl, mesoradazine, methadone, pimozide, procainamide, quinidine, sotalol, terfenadine

- Pregnancy

- Clinically relevant findings in the ECG

- Participation in another clinical study during the preceding 30 days1 (last treatment

from previous study to first treatment of new study)

- Criteria which in the opinion of the investigator preclude participation for

scientific reasons, for reasons of compliance, or for reasons of the patient's safety

- Patients taking another fluoroquinolone at the time of planned moxifloxacin dosing

Locations and Contacts

Little Rock, Arkansas 72202, United States

Orange, California 92868-3974, United States

San Diego, California 92123-4282, United States

Louisville, Kentucky 40202, United States

New Orleans, Louisiana 70118-5799, United States

Boston, Massachusetts 02115, United States

Kansas City, Missouri 64108-9898, United States

Cincinnati, Ohio 45229-3039, United States

Cleveland, Ohio 44106, United States

Toledo, Ohio 43606, United States

Salt Lake City, Utah 84132, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here and search for information of websynopsis results

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: May 2010
Last updated: July 21, 2015

Page last updated: August 23, 2015

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