Gram Positive Infection Clinical Trial
Official title:
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
Verified date | April 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: IntegReview Ethical Review Board |
Study type | Interventional |
Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in phagocytosis of gram-negative bacteria by neutrophils | Baseline, day 4 and day 5 | Yes | |
Primary | Change from baseline in phagocytosis of gram-negative bacteria by monocytes | Baseline, day 4 and day 5 | Yes | |
Primary | Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | Yes | |
Primary | Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | Yes | |
Primary | Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | Yes | |
Primary | Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | Yes | |
Primary | Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | Yes | |
Secondary | Linezolid peak concentration on day 4 | day 4 | No | |
Secondary | Linezolid peak concentration on day 5 | day 5 | No | |
Secondary | Linezolid trough concentration on day 5 | day 5 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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