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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01291602

Enrollment

Registered

2011-02-08

Start date

2011-02-28

Completion date

2011-04-30

Last updated

2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male and Female Japanese Volunteers

Keywords

NXL104, ceftazidime, CAZ104, Healthy Japanese volunteers, Phase 1, Single and Multiple Dose Study

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.

Interventions

DRUGNXL104

IV Solution

DRUGCAZ104

IV Solution

DRUGPlacebo

IV saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026