Trial Outcomes & Findings for Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis (NCT NCT02444234)
NCT ID: NCT02444234
Last Updated: 2020-06-02
Results Overview
Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
2 days
Results posted on
2020-06-02
Participant Flow
This was a cross-over study where patients with CF received tedizolid 200mg IV or PO once daily for 3 doses followed by a minimum 2 day washout and receipt of the remaining dosage form.
Participant milestones
| Measure |
Tedizolid PO/IV
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a minimum 2-day washout.
|
Tedizolid IV/PO
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a minimum 2-day washout.
|
|---|---|---|
|
First Intervention (3 Days)
STARTED
|
6
|
5
|
|
First Intervention (3 Days)
COMPLETED
|
6
|
5
|
|
First Intervention (3 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Day Minimum)
STARTED
|
6
|
5
|
|
Washout (2 Day Minimum)
COMPLETED
|
6
|
5
|
|
Washout (2 Day Minimum)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Days)
STARTED
|
6
|
5
|
|
Second Intervention (3 Days)
COMPLETED
|
6
|
5
|
|
Second Intervention (3 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
Participants were randomized to receive either tedizolid oral 200 mg tablet or IV 200 mg once daily for 3 days and crossed over to either IV or PO after a minimum of 2 day washout period
|
|---|---|
|
Age, Continuous
|
27.27 years
STANDARD_DEVIATION 4.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Creatinine Clearance
|
147.6 mL/min
STANDARD_DEVIATION 32.43 • n=5 Participants
|
|
Body Mass Index
|
21.72 kg/m2
STANDARD_DEVIATION 3.60 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysCmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome measures
| Measure |
Tedizolid PO
n=11 Participants
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=11 Participants
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
Peak Plasma Concentration (Cmax)
|
2.22 mg/liter
Standard Deviation 0.745
|
2.92 mg/liter
Standard Deviation .624
|
PRIMARY outcome
Timeframe: 2 daysArea under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose\*F/CL
Outcome measures
| Measure |
Tedizolid PO
n=11 Participants
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=11 Participants
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
|
22.1 mg*h/mL
Standard Deviation 5.72
|
20.7 mg*h/mL
Standard Deviation 3.92
|
PRIMARY outcome
Timeframe: 2 daysTmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome measures
| Measure |
Tedizolid PO
n=11 Participants
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=11 Participants
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
Time to Peak Plasma Concentration (Tmax)
|
2.5 hours
Standard Deviation 1.33
|
1.36 hours
Standard Deviation 0.369
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One patient could not produce sputum
Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.
Outcome measures
| Measure |
Tedizolid PO
n=10 Participants
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=10 Participants
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
Peak Sputum Concentration
|
1.08 mg/liter
Standard Deviation 0.6
|
1.196 mg/liter
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One patient could not produce sputum
AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome measures
| Measure |
Tedizolid PO
n=10 Participants
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=10 Participants
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
Area Under the Sputum Concentration Versus Time Curve (AUC)
|
15.04 mg*h/mL
Standard Deviation 8.92
|
13.53 mg*h/mL
Standard Deviation 7.203
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One patient could not produce sputum
Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.
Outcome measures
| Measure |
Tedizolid PO
n=10 Participants
Tedizolid phophate 200mg tablet with crossover to IV
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=10 Participants
Tedizolid phophate 200mg IV with crossover to PO
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
Time to Peak Sputum Concentration (Tmax)
|
4 hours
Standard Deviation 0
|
3 hours
Standard Deviation 0
|
Adverse Events
Tedizolid PO
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tedizolid IV
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 |
Tedizolid PO
n=11 participants at risk
Tedizolid phophate 200mg tablet
Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
|
Tedizolid IV
n=11 participants at risk
Tedizolid phophate 200mg IV
Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
|
|---|---|---|
|
General disorders
Diarrhea
|
9.1%
1/11 • Number of events 1 • 10 days
|
9.1%
1/11 • Number of events 1 • 10 days
|
Additional Information
Paul M Beringer, Pharm.D.
University of Southern California
Phone: 323-442-1402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place