Trial Outcomes & Findings for A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance (NCT NCT01556633)
NCT ID: NCT01556633
Last Updated: 2016-07-07
Results Overview
CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose. CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed\[0-48\])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC\[0-48\]) CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed\[0-8\]/AUC\[0-8\] + Aed\[24-32\]/AUC\[24-32\]) / 2 CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed\[8-16\]/AUC\[8-16\] + Aed\[16-24\]/AUC\[16-24\] + Aed\[32-48\]/AUC\[32-48\]) / 3
COMPLETED
PHASE1
16 participants
CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood
2016-07-07
Participant Flow
A total of 27 participants were screened and 16 participants were enrolled in the study. The study was conducted from 09 March 2012 to 23 June 2012 at two study centers in New Zealand.
Participant milestones
| Measure |
Dialysis (Oseltamivir 75 mg)
Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance
Baseline characteristics by cohort
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 Participants
Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 16.62 • n=5 Participants
|
66.3 Years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
57.9 Years
STANDARD_DEVIATION 15.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for bloodPopulation: Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population.
CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose. CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed\[0-48\])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC\[0-48\]) CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed\[0-8\]/AUC\[0-8\] + Aed\[24-32\]/AUC\[24-32\]) / 2 CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed\[8-16\]/AUC\[8-16\] + Aed\[16-24\]/AUC\[16-24\] + Aed\[32-48\]/AUC\[32-48\]) / 3
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=9 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Oseltamivir Carboxylate, CLDCCPD
|
0.326 Litre (L)/hour (h)
Geometric Coefficient of Variation 18.5
|
—
|
|
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Oseltamivir, CLDAPD
|
NA Litre (L)/hour (h)
Geometric Coefficient of Variation NA
CLDAPD is a derived from CLDCCPD and CLDCAPD. Since CLDCAPD could not be calculated as no oseltamivir concentration was found in the dialysate; therefore, CLDAPD could not be derived.
|
—
|
|
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Oseltamivir, CLDCAPD
|
NA Litre (L)/hour (h)
Geometric Coefficient of Variation NA
CLDCAPD could not be calculated as no oseltamivir concentration was found in the dialysate.
|
—
|
|
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Oseltamivir, CLDCCPD
|
0.183 Litre (L)/hour (h)
Geometric Coefficient of Variation 23.8
|
—
|
|
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Oseltamivir Carboxylate CLDAPD
|
0.230 Litre (L)/hour (h)
Geometric Coefficient of Variation 13.1
|
—
|
|
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Oseltamivir Carboxylate, CLDCAPD
|
0.187 Litre (L)/hour (h)
Geometric Coefficient of Variation 11.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dosePopulation: PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=9 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
AUC120 oseltamivir (n = 6)
|
175 nanogram (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 33.3
|
—
|
|
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
AUC168 oseltamivir (n = 6)
|
175 nanogram (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 33.3
|
—
|
|
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
AUCinf oseltamivir (n = 6)
|
175 nanogram (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 33.3
|
—
|
|
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
AUC120 oseltamivir carboxylate (n = 9)
|
83400 nanogram (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 88.9
|
—
|
|
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
AUC168 oseltamivir carboxylate (n = 9)
|
89200 nanogram (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 96.0
|
—
|
|
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
AUCinf oseltamivir carboxylate (n = 9)
|
93800 nanogram (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 102.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dosePopulation: PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=6 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose
AUCinf, oseltamivir (n = 3)
|
64.7 ng*h/mL
Geometric Coefficient of Variation 46.2
|
—
|
|
AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose
AUCinf, oseltamivir carboxylate (n = 6)
|
8630 ng*h/mL
Geometric Coefficient of Variation 56.3
|
—
|
PRIMARY outcome
Timeframe: Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dosePopulation: PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=9 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Cmax of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir (n = 9,5)
|
67.1 ng/mL
Geometric Coefficient of Variation 79.4
|
22.1 ng/mL
Geometric Coefficient of Variation 38.2
|
|
Cmax of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate (n = 9,6)
|
1710 ng/mL
Geometric Coefficient of Variation 31.0
|
361 ng/mL
Geometric Coefficient of Variation 27.4
|
PRIMARY outcome
Timeframe: Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dosePopulation: PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis.
C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=9 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
C120h, oseltamivir carboxylate
|
301.0 ng/mL
Standard Deviation 264.0
|
—
|
|
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
C120h, oseltamivir
|
NA ng/mL
Standard Deviation NA
For all participants the oseltamivir concentration was below lower limit of quantification and therefore a mean could not be calculated.
|
—
|
|
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
C168h,oseltamivir
|
NA ng/mL
Standard Deviation NA
For all participants the oseltamivir concentration was below lower limit of quantification and therefore a mean could not be calculated.
|
—
|
|
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Clast, oseltamivir
|
1.30 ng/mL
Standard Deviation 0.271
|
—
|
|
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
C168h,oseltamivir carboxylate
|
138.0 ng/mL
Standard Deviation 135.0
|
—
|
|
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Clast, oseltamivir carboxylate
|
140.0 ng/mL
Standard Deviation 132.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dosePopulation: PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration. The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=9 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate
T1/2, Oseltamivir (n = 6,3)
|
1.92 h
Interval 1.01 to 2.41
|
2.25 h
Interval 1.12 to 3.39
|
|
Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate
Tmax, Oseltamivir (n = 9, 5)
|
2.50 h
Interval 0.5 to 4.0
|
1.33 h
Interval 0.5 to 4.0
|
|
Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate
Tmax, Oseltamivir carboxylate (n = 9, 6)
|
20.00 h
Interval 6.67 to 28.0
|
7.34 h
Interval 6.67 to 12.07
|
|
Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate
T1/2, Oseltamivir Carboxylate (n = 9,6)
|
35.3 h
Interval 10.0 to 47.3
|
10.7 h
Interval 8.87 to 21.0
|
PRIMARY outcome
Timeframe: Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.Population: PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=9 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate
CLR, oseltamivir carboxylate (n = 4, 6)
|
0.655 L/h
Geometric Coefficient of Variation 217.4
|
2.28 L/h
Geometric Coefficient of Variation 81.3
|
|
Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate
CLR, oseltamivir (n = 4, 5)
|
0.572 L/h
Geometric Coefficient of Variation 441.3
|
3.30 L/h
Geometric Coefficient of Variation 70.6
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)
Any AEs
|
9 participants
|
2 participants
|
|
Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)
Any SAEs
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase \[ALT\], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis. Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
Sodium chloride
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
Chloride
|
3 participants
|
0 participants
|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
Phosphate
|
3 participants
|
0 participants
|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
Calcium
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
Glucose (random)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
Bicarbonate
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Abnormality in Laboratory Measurements
ALT
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Baseline (Day -1) to Follow-up visit (Days 15 to 22)Population: Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond \[msec\]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as \<=30, \>30-60, and \>60 msec increase from baseline.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
QT, <= 30
|
8 participants
|
6 participants
|
|
Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
QT, > 30 - 60
|
2 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
QTcB, <= 30
|
10 participants
|
6 participants
|
|
Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
QTcF, <= 30
|
9 participants
|
6 participants
|
|
Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
QTcF, > 30 - 60
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)Population: Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature. Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as \<=70 mmHg (SBP) and \<=40 mmHg (DBP); high blood pressure defined as \>=140 mmHg (SBP) and \>=90 mmHg (DBP); low temperature defined as \<=36.5 degrees Celsius and high temperature defined as \>=37.5 degrees Celsius.
Outcome measures
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 Participants
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 Participants
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Day 2, High
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP , Day 1 - postdose, High
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Day 3, High
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Day 4, High
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Day 5, High
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Day 7, High
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Day 8, High
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
SBP, Follow Up, High
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
DBP, Day 2, High
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
DBP, Day 3, High
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
DBP, Day 7, High
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
DBP, Day 8, High
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
DBP, Follow Up, High
|
3 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
Temperature, Day 4, Low
|
2 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
Temperature, Day 6, Low
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
Temperature, Day 7, Low
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
Temperature, Day 8, Low
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Shifts in Vital Signs
Temperature, Follow Up, Low
|
2 participants
|
0 participants
|
Adverse Events
Dialysis (Oseltamivir 75 mg)
Reduced Creatinine Clearance (Oseltamivir 30 mg)
Serious adverse events
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 participants at risk
Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 participants at risk
Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
Other adverse events
| Measure |
Dialysis (Oseltamivir 75 mg)
n=10 participants at risk
Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
|
Reduced Creatinine Clearance (Oseltamivir 30 mg)
n=6 participants at risk
Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
16.7%
1/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
16.7%
1/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
General disorders
Catheter site hematoma
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
General disorders
Edema peripheral
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Eye disorders
Conjunctivitis allergic
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Nervous system disorders
Dizziness postural
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
16.7%
1/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Nervous system disorders
Parasthesia
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
2/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
2/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
0.00%
0/6 • Approximately 7 weeks
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER