NCT01049022

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 3 Months – 14 Years
• Healthy volunteers: Not accepted

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

• Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-12-01
• Completion: 2013-08-01
• First posted: 2010-01-14
• Last updated: 2015-07-22

Locations

11 sites across 1 country: United States