A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects

Phase 1 Completed 15 enrolled Pfizer

RandomizedParallel-groupDouble-blindBasic science

Summary

This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.

Timeline

Start: 2011-02
Primary completion: 2011-04
Completion: 2011-04

Publications

Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	avibactam	Small molecule	500 mg	Intravenous
Background	Ceftazidime	Small molecule	2000 mg	Intravenous

Indications

No indication recorded.