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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
15
Research Site
Glendale, California, United States
Research Site
Baltimore, Maryland, United States
Adverse events will be monitored as a measure of safety and tolerability
Time frame: 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
Time frame: A range of 12 days
The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime
Time frame: Range of 8 days
The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime
Time frame: Range of 8 days
The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime
Time frame: Range of 12 days
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