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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

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NCT01291602

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Research Site
Glendale, California, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Male and Female Japanese Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 ?-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

NCT01291602
Pfizer
Completed
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

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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
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ?-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
Sexes Eligible for Study: All
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01291602
D4280C00010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Paul Newell, MD AstraZeneca
Principal Investigator: Mark Yen, MD PAREXEL Early Phase/California Clinical Trials Medical Group
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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