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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Male and Female Japanese Volunteers
- Sponsor
- Pfizer
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Adverse events will be monitored as a measure of safety and tolerability
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Placebo
Three Japanese subjects to receive placebo IV doses
Intervention: Placebo
NXL104
Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
Intervention: NXL104
Ceftazidime NXL104 (CAZ104)
Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime
Intervention: CAZ104
Outcomes
Primary Outcomes
Adverse events will be monitored as a measure of safety and tolerability
Time Frame: A range of 12 days
Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
Time Frame: A range of 12 days
Secondary Outcomes
- The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime(Range of 8 days)
- The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime(Range of 8 days)
- The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime(Range of 12 days)