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

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

December 31, 2012

Study Completion Date

August 31, 2013

Conditions
Infections
Interventions
DRUG

Moxifloxacin (Avelox, BAY12-8039)

Single intravenous (IV) infusion of moxifloxacin administered over 60 minutes, at an initial dosage of 5 milligram per kilogram per body weight (mg/kg/BW) with dose escalation to 6 mg/kg in subjects of age 6 years (yrs) to less than or equal to (\<=) 14 years.

DRUG

Moxifloxacin (Avelox, BAY12-8039)

Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 7 mg/kg/BW with dose escalation to 8 mg/kg in subjects of age 2 years to less than (\<) 6 years; dose escalation was based on evaluations of the pharmacokinetic (PK) and safety data from the subjects in a preceding cohort.

DRUG

Moxifloxacin (Avelox, BAY12-8039)

Single IV infusion of moxifloxacin administered over 60 minutes, at a dosage of 9 mg/kg/BW with dose escalation to 10 mg/kg in subjects of age 3 months to \< 2 years; dose escalation was based on evaluations of the PK and safety data from the subjects in a preceding cohort.

Trial Locations (11)

40202

Louisville

43606

Toledo

44106

Cleveland

72202

Little Rock

84132

Salt Lake City

92868-3974

Orange

92123-4282

San Diego

70118-5799

New Orleans

02115

Boston

64108-9898

Kansas City

45229-3039

Cincinnati

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY