Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albany College of Pharmacy and Health Sciences; Amit.Pai
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Oxazolidinones; Tedizolid; Tedizolid phosphate; Torezolid; Torezolid phosphate

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