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
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Male and Female Japanese Volunteers
In brief
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.
Key facts
- Study ID
- NCT01291602
- Run by
- Pfizer
- People needed
- 15
- Starts
- 2011-02-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2017-09-01
Who can join
Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Glendale, California, United States
- Research Site — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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