NCT01291602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

February 6, 2011

Last Update Submit

August 31, 2017

Conditions

Healthy Male and Female Japanese Volunteers

Keywords

NXL104ceftazidimeCAZ104Healthy Japanese volunteersPhase 1Single and Multiple Dose Study

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

NXL104

EXPERIMENTAL

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

Drug: NXL104

Placebo

PLACEBO COMPARATOR

Three Japanese subjects to receive placebo IV doses

Drug: Placebo

Ceftazidime NXL104 (CAZ104)

EXPERIMENTAL

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

Drug: CAZ104

Interventions

NXL104DRUG

IV Solution

NXL104
CAZ104DRUG

IV Solution

Ceftazidime NXL104 (CAZ104)
PlaceboDRUG

IV saline

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, United States

Location

Research Site

Baltimore, Maryland, United States

Location

Related Publications (1)

  • Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

    PMID: 30221827DERIVED

Related Links

MeSH Terms

Interventions

avibactam

Study Officials

  • Paul Newell, MD

    AstraZeneca

    STUDY DIRECTOR

  • Mark Yen, MD

    PAREXEL Early Phase/California Clinical Trials Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2011

First Posted

February 8, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

US(2)