A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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
Sponsor study identifier
interventional
15
1 country
2
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 6, 2011
Actual (reported)February 8, 2011
Actual (reported)April 2011
Actual (reported)April 2011
Actual (reported)Adverse events will be monitored as a measure of safety and tolerability
A range of 12 days
Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
A range of 12 days
The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime
Range of 8 days
The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime
Range of 8 days
The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime
Range of 12 days
Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
Three Japanese subjects to receive placebo IV doses
Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime
Research Site
Glendale, California, United States
Research Site
Baltimore, Maryland, United States
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.
Paul Newell, MD
AstraZeneca
Mark Yen, MD
PAREXEL Early Phase/California Clinical Trials Medical Group
15 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2011
First Posted
February 8, 2011
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
IV saline
Contact the study team to confirm eligibility.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)Last Updated
September 1, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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