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

NCT02342418 | Completed Phase 4 Results

• 1 other identifier: 14-019
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour\*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.

  12 months

Secondary Outcomes (1)

• This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects

  12 months

Study Arms (2)

Morbidly obese

ACTIVE COMPARATOR

The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.

Drug: Tedizolid phosphate

Non-obese

ACTIVE COMPARATOR

Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.

Drug: Tedizolid phosphate

Interventions

Tedizolid phosphate DRUG

Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.

Also known as: Sivextro

Morbidly obese; Non-obese

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amit.Pai: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Pai MP. Pharmacokinetics of Tedizolid in Morbidly Obese and Covariate-Matched Nonobese Adults. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4585-9. doi: 10.1128/AAC.00682-16. Print 2016 Aug.

  PMID: 27185808 RESULT

MeSH Terms

Conditions

Obesity

Interventions

tedizolid phosphate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Most of the participants were below 130 kg and so these data should not be extrapolated to adults above 130 kg.

Results Point of Contact

• Title: Manjunath Pai, Associate Professor
• Organization: University of Michigan

amitpai@med.umich.edu

7346470006

Study Officials

• Manjunath Pai, PharmD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 21, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share