Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age

Phase 2 Completed 59 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

NaSingle-groupOpen-labelTreatment

Summary

To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).

Timeline

Start: 2007-12
Primary completion: 2009-09
Completion: 2009-09

Publications

Purdy J, Jouve S, Yan JL, Balter I, Dartois N, Cooper CA, Korth-Bradley J. Pharmacokinetics and safety profile of tigecycline in children aged 8 to 11 years with selected serious infections: a multicenter, open-label, ascending-dose study. Clin Ther. 2012 Feb;34(2):496-507.e1. doi: 10.1016/j.clinthera.2011.12.010. Epub 2012 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tigecycline	Small molecule	0.75 mg/kg	Intravenous
Subject	Tigecycline	Small molecule	1 mg/kg	Intravenous
Subject	Tigecycline	Small molecule	1.25 mg/kg	Intravenous

Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age

Summary

Timeline

Publications

Drugs

Indications