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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

Last updated on February 22, 2019

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Study Location
Research Site
Glendale, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Male and Female Japanese Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 ?-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

NCT01291602
Pfizer
Completed
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

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