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

February 6, 2011
May 16, 2011
February 2011
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01291602 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Male and Female Japanese Volunteers
  • Drug: NXL104
    IV Solution
  • Drug: CAZ104
    IV Solution
  • Drug: Placebo
    IV saline
  • Experimental: NXL104
    Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
    Intervention: Drug: NXL104
  • Placebo Comparator: Placebo
    Three Japanese subjects to receive placebo IV doses
    Intervention: Drug: Placebo
  • Experimental: Ceftazidime NXL104 (CAZ104)
    Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime
    Intervention: Drug: CAZ104
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291602
D4280C00010
No
Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Paul Newell, MD AstraZeneca
Principal Investigator: Mark Yen, MD PAREXEL Early Phase/California Clinical Trials Medical Group
AstraZeneca
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP