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 identifier:D4280C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Healthy male and female Japanese volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
NXL104, CAZ104, Placebo
Sex
All
Actual Enrollment
15
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Apr 2011
Study Completion Date: 01 Apr 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Paul Newell
AstraZeneca
