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
20 Years
45 Years
Not Enrolling
Male
Gram Positive Infection
Male
Gram Positive Infection
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 Site | Farmington, Connecticut 06030-3805 |
