Know Cancer

or
forgot password

An Open-label, Placebo-controlled Phase 1 Study to Evaluate the Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Male Subjects


Phase 1
20 Years
45 Years
Not Enrolling
Male
Gram Positive Infection

Thank you

Trial Information

An Open-label, Placebo-controlled Phase 1 Study to Evaluate the Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Male Subjects


Inclusion Criteria:



- Healthy male subjects between the ages of 20 and 45 years, inclusive (Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lbs).

Exclusion Criteria:

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- Subject who had a bacterial/viral infection within 2 weeks prior to the first dose of
study medication.

- Subjects with current or prior neutropenia (eg, <1.4 x 109 neutrophils /L).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Change from baseline in phagocytosis of gram-negative bacteria by neutrophils

Outcome Time Frame:

Baseline, day 4 and day 5

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: IntegReview Ethical Review Board

Study ID:

A5951164

NCT ID:

NCT01544673

Start Date:

March 2012

Completion Date:

April 2012

Related Keywords:

  • Gram Positive Infection

Name

Location

Pfizer Investigational SiteFarmington, Connecticut  06030-3805