Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01544673

Enrollment

Registered

2012-03-06

Start date

2012-03-31

Completion date

2012-04-30

Last updated

2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram Positive Infection

Brief summary

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.

Interventions

DRUGlinezolid

600 mg oral tablet twice daily for 4.5 days

DRUGPlacebo

500 mg oral placebo twice daily for 4.5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation	Baseline, day 4 and day 5
Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation	Baseline, day 4 and day 5
Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation	Baseline, day 4 and day 5
Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation	Baseline, day 4 and day 5
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils	Baseline, day 4 and day 5
Change from baseline in phagocytosis of gram-negative bacteria by monocytes	Baseline, day 4 and day 5
Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation	Baseline, day 4 and day 5

Secondary

Measure	Time frame
Linezolid peak concentration on day 5	day 5
Linezolid trough concentration on day 5	day 5
Linezolid peak concentration on day 4	day 4

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026