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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Male and Female Japanese Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NXL104

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

Group Type EXPERIMENTAL

NXL104

Intervention Type DRUG

IV Solution

Placebo

Three Japanese subjects to receive placebo IV doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV saline

Ceftazidime NXL104 (CAZ104)

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

Group Type EXPERIMENTAL

CAZ104

Intervention Type DRUG

IV Solution

Interventions

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NXL104

IV Solution

Intervention Type DRUG

CAZ104

IV Solution

Intervention Type DRUG

Placebo

IV saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes