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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 45
Updated:9/2/2017
Start Date:February 2011
End Date:April 2011

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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

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.


Inclusion Criteria:

- To be considered as 'Japanese', both of the volunteer's parents, and all grandparents
must be Japanese. The volunteer must have been born in Japan, have a valid Japanese
passport and must not have lived outside Japan for more than 5 years

- Have a body mass index (BMI) between 17 and 27 kg/m2 inclusive and weigh at least 45
kg and no more than 100 kg.

- Females must not be lactating, and must be of non-childbearing potential
(post-menopausal at least 12 months or documented irreversible surgical sterilization
by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal
ligation

Exclusion Criteria:

- History or presence of gastrointestinal, liver or kidney disease, or other conditions
known to interfere with the absorption, distribution, metabolism, or excretion of
drugs

- Symptoms of a clinically significant illness in the 3 months before the study

- History of hypersensitivity (eg, anaphylaxis), serious allergy, or any serious
reaction to carbapenem, cephalosporins, or other β-lactam antibiotics

- Use within 14 days prior to the first study dose of any over-the-counter (including
St. John's Wort or any herbal products) or prescription medication

- Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the
previous 3 months
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