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
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca; Pfizer
• Treatments: Avibactam; Ceftazidime

Criteria

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