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 |
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.
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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