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

Phase 1

Completed

• Conditions: Healthy Male and Female Japanese Volunteers
• Interventions: Drug: NXL104; Drug: CAZ104; Drug: Placebo

• Registration Number: NCT01291602
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-06
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NXL104	NXL104	Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
Ceftazidime NXL104 (CAZ104)	CAZ104	Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime
Placebo	Placebo	Three Japanese subjects to receive placebo IV doses

Primary Outcome Measures

Name	Time	Method
Adverse events will be monitored as a measure of safety and tolerability	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	A range of 12 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Baltimore, Maryland, United States