Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT02342418
Eligibility Criteria:
Inclusion Criteria:
* Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers
* Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min
* Female subjects of childbearing potential (CBP) either surgically sterilized, using hormonal contraceptives or an effective barrier method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from the time of pre-study screening, during the entire study period and 4 weeks following the study period
* Platelets count ≥ 140,000/mL
* Absolute neutrophil count (ANC) ≥ 1800/mL
Exclusion Criteria:
* History of hypersensitivity reaction to any oxazolidinone
* BMI \< 18.5 kg/m2
* Any chronic medical condition requiring pharmacologic therapy
* Transaminases (AST or ALT) \> 2.5 x upper limit of normal
* Total bilirubin \> 1.5 x upper limit of normal
* Positive urine pregnancy test (if female)
* Abnormal electrocardiogram (ECG) as judged by the study physician
* Unable to tolerate venipuncture and multiple blood draws
* Clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up
* Unable to independently provide a written informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02342418
Study Brief:
Protocol Section:
NCT02342418