Trial Outcomes & Findings for Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults (NCT NCT02342418)
NCT ID: NCT02342418
Last Updated: 2017-03-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
12 months
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Morbidly Obese
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Non-obese
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Morbidly Obese
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Non-obese
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
Baseline characteristics by cohort
| Measure |
Morbidly Obese
n=9 Participants
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Non-obese
n=9 Participants
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=99 Participants
|
37 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Body Mass Index
|
43.5 kilogram per square meter
n=99 Participants
|
27.4 kilogram per square meter
n=107 Participants
|
36.1 kilogram per square meter
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Morbidly Obese
n=9 Participants
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Non-obese
n=9 Participants
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
|---|---|---|
|
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 hour*milligram/Liter
Interval 18.0 to 42.0
|
27.2 hour*milligram/Liter
Interval 22.4 to 56.0
|
SECONDARY outcome
Timeframe: 12 monthsThe maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.
Outcome measures
| Measure |
Morbidly Obese
n=9 Participants
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Non-obese
n=9 Participants
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
|---|---|---|
|
This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects
|
2.38 Milligram per Liter
Interval 1.28 to 3.99
|
2.96 Milligram per Liter
Interval 2.16 to 5.27
|
Adverse Events
Morbidly Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-obese
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Morbidly Obese
n=9 participants at risk
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
Non-obese
n=10 participants at risk
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.
Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
|
|---|---|---|
|
Blood and lymphatic system disorders
Intravascular Infiltration
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
Additional Information
Manjunath Pai, Associate Professor
University of Michigan
Phone: 7346470006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place