Phase 4
N=19
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02342418 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: 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 hour*milligram/Liter — p=0.314
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tedizolid phosphate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amit.Pai
- Primary completion
- Sep 2015
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 |
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.
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). 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.