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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Male and Female Japanese Volunteers

Treatments: Drug: NXL104; Drug: CAZ104; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291602

D4280C00010

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups, including a placebo group

NXL104

Experimental group

Description:

Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104

Treatment:

Drug: NXL104

Placebo

Placebo Comparator group

Description:

Three Japanese subjects to receive placebo IV doses

Treatment:

Drug: Placebo

Ceftazidime NXL104 (CAZ104)

Experimental group

Description:

Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime

Treatment:

Drug: CAZ104