Phase 4
Completed N=19
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
Source: ClinicalTrials.gov NCT02342418 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects. — 26.0; 27.2 hour*milligram/Liter — p=0.314
◆ Published Evidence
Established
22citations · ~2 / year
Pharmacokinetics of Tedizolid in Morbidly Obese and Covariate-Matched Nonobese Adults.
Summary
This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal body weight- matched non-obese subjects. Qualifying subjects who have completed an informed consent will receive a single intravenous dose of tedizolid with the collection of 11 blood samples over 72 hours post dose.
Linked Publications
-
Pharmacokinetics of Tedizolid in Morbidly Obese and Covariate-Matched Nonobese Adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects. |
26.0; 27.2 | 0.314 |
| SECONDARY This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects |
2.38; 2.96 | 0.214 |
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 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
Data sourced from ClinicalTrials.gov (NCT02342418) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.