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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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01291602
First received: February 6, 2011
Last updated: May 16, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Male and Female Japanese Volunteers
 Drug: NXL104
Drug: CAZ104
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events will be monitored as a measure of safety and tolerability [ Time Frame: A range of 12 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime [ Time Frame: Range of 8 days ] [ Designated as safety issue: No ]
  • The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime [ Time Frame: Range of 8 days ] [ Designated as safety issue: No ]
  • The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime [ Time Frame: Range of 12 days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NXL104
Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
 Drug: NXL104
IV Solution
Placebo Comparator: Placebo
Three Japanese subjects to receive placebo IV doses
 Drug: Placebo
IV saline
Experimental: Ceftazidime NXL104 (CAZ104)
Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime
 Drug: CAZ104
IV Solution

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291602

Locations
United States, California
Research Site
Glendale, California, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paul Newell, MD AstraZeneca
Principal Investigator: Mark Yen, MD PAREXEL Early Phase/California Clinical Trials Medical Group
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01291602     History of Changes
Other Study ID Numbers: D4280C00010
Study First Received: February 6, 2011
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AstraZeneca:
NXL104
ceftazidime
CAZ104
 Healthy Japanese volunteers
Phase 1
Single and Multiple Dose Study

Additional relevant MeSH terms:
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013