Trial Outcomes & Findings for A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD) (NCT NCT02617784)
NCT ID: NCT02617784
Last Updated: 2016-02-15
Results Overview
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).
COMPLETED
PHASE1
24 participants
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose
2016-02-15
Participant Flow
Participant milestones
| Measure |
Oseltamivir With HD
Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
Oseltamivir With CAPD
Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
First Dose Assessment Period
|
12
|
12
|
|
Overall Study
Second Dose Assessment Period
|
11
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Baseline characteristics by cohort
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
Oseltamivir With CAPD
n=12 Participants
Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.00 years
STANDARD_DEVIATION 13.23 • n=99 Participants
|
54.42 years
STANDARD_DEVIATION 14.30 • n=107 Participants
|
51.21 years
STANDARD_DEVIATION 13.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dosePopulation: Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period.
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5
|
20.2 ng/mL
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dosePopulation: PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period.
Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=11 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Oseltamivir in HD Participants During Days 38 to 43
|
22.6 ng/mL
Standard Deviation 9.69
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
|
943 ng/mL
Standard Deviation 393
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=11 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
|
1120 ng/mL
Standard Deviation 320
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng\*h/mL).
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5
AUC12
|
63.9 ng*h/mL
Standard Deviation 24.6
|
|
Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5
AUClast
|
62.1 ng*h/mL
Standard Deviation 26.8
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=11 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Oseltamivir in HD Participants During Days 38 to 43
AUC12
|
68.5 ng*h/mL
Standard Deviation 19.5
|
|
AUC of Oseltamivir in HD Participants During Days 38 to 43
AUClast
|
65.6 ng*h/mL
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
AUC42
|
31600 ng*h/mL
Standard Deviation 14100
|
|
AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
AUClast
|
44400 ng*h/mL
Standard Deviation 19000
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=11 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
AUC42
|
38200 ng*h/mL
Standard Deviation 11500
|
|
AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
AUClast
|
60400 ng*h/mL
Standard Deviation 16700
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Oseltamivir in CAPD Participants During Days 1 to 6
|
32.0 ng/mL
Standard Deviation 20.4
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Oseltamivir in CAPD Participants During Days 36 to 43
|
27.7 ng/mL
Standard Deviation 15.9
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
|
885 ng/mL
Standard Deviation 244
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
|
849 ng/mL
Standard Deviation 200
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Oseltamivir in CAPD Participants During Days 1 to 6
AUC12
|
85.6 ng*h/mL
Standard Deviation 40.7
|
|
AUC of Oseltamivir in CAPD Participants During Days 1 to 6
AUClast
|
78.5 ng*h/mL
Standard Deviation 41.8
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Oseltamivir in CAPD Participants During Days 36 to 43
AUC12
|
72.4 ng*h/mL
Standard Deviation 28.3
|
|
AUC of Oseltamivir in CAPD Participants During Days 36 to 43
AUClast
|
67.7 ng*h/mL
Standard Deviation 27.7
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
AUC48
|
33400 ng*h/mL
Standard Deviation 9700
|
|
AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
AUClast
|
56800 ng*h/mL
Standard Deviation 18300
|
PRIMARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dosePopulation: PK Analysis Population (Second Dose Subpopulation).
Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng\*h/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
AUC48
|
32400 ng*h/mL
Standard Deviation 8210
|
|
AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
AUClast
|
60800 ng*h/mL
Standard Deviation 18800
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dosePopulation: PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis.
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
0 hours from D1 dose (n=12)
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
1 hour from D1 dose (n=12)
|
18.0 ng/mL
Standard Deviation 14.2
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
2 hours from D1 dose (n=12)
|
12.5 ng/mL
Standard Deviation 6.58
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
4 hours from D1 dose (n=12)
|
6.06 ng/mL
Standard Deviation 2.37
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
8 hours from D1 dose (n=12)
|
1.93 ng/mL
Standard Deviation 1.64
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
12 hours from D1 dose (n=12)
|
0.513 ng/mL
Standard Deviation 0.783
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
20 hours from D1 dose (n=12)
|
0.104 ng/mL
Standard Deviation 0.361
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
32 hours from D1 dose (n=12)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
42 hours from D1 dose (n=12)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
48 hours from D1 dose (n=12)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
49 hours from D1 dose (n=12)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
90 hours from D1 dose (n=12)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
0 hours from D38 dose (n=11)
|
0.413 ng/mL
Standard Deviation 0.938
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
1 hour from D38 dose (n=11)
|
21.5 ng/mL
Standard Deviation 9.96
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
2 hours from D38 dose (n=11)
|
15.4 ng/mL
Standard Deviation 5.98
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
4 hours from D38 dose (n=11)
|
6.07 ng/mL
Standard Deviation 2.80
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
8 hours from D38 dose (n=11)
|
1.30 ng/mL
Standard Deviation 0.801
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
12 hours from D38 dose (n=11)
|
0.193 ng/mL
Standard Deviation 0.429
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
20 hours from D38 dose (n=11)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
32 hours from D38 dose (n=11)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
42 hours from D38 dose (n=11)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
48 hours from D38 dose (n=11)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
49 hours from D38 dose (n=11)
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
114 hours from D38 dose (n=11)
|
0.0 ng/mL
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dosePopulation: PK Analysis Population; n = number of participants included at specified timepoints in the analysis.
Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
0 hours from D1 dose (n=12)
|
0.908 ng/mL
Standard Deviation 3.15
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
1 hour from D1 dose (n=12)
|
25.7 ng/mL
Standard Deviation 24.5
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
2 hours from D1 dose (n=12)
|
107 ng/mL
Standard Deviation 83.7
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
4 hours from D1 dose (n=12)
|
276 ng/mL
Standard Deviation 181
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
8 hours from D1 dose (n=12)
|
589 ng/mL
Standard Deviation 321
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
12 hours from D1 dose (n=12)
|
772 ng/mL
Standard Deviation 363
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
20 hours from D1 dose (n=12)
|
908 ng/mL
Standard Deviation 383
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
32 hours from D1 dose (n=12)
|
926 ng/mL
Standard Deviation 399
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
42 hours from D1 dose (n=12)
|
877 ng/mL
Standard Deviation 393
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
48 hours from D1 dose (n=12)
|
212 ng/mL
Standard Deviation 78.6
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
90 hours from D1 dose (n=12)
|
240 ng/mL
Standard Deviation 123
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
0 hours from D38 dose (n=11)
|
59.0 ng/mL
Standard Deviation 32.1
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
1 hour from D38 dose (n=11)
|
95.0 ng/mL
Standard Deviation 32.8
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
2 hours from D38 dose (n=11)
|
200 ng/mL
Standard Deviation 58.7
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
4 hours from D38 dose (n=11)
|
413 ng/mL
Standard Deviation 137
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
12 hours from D38 dose (n=11)
|
933 ng/mL
Standard Deviation 295
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
20 hours from D38 dose (n=11)
|
1090 ng/mL
Standard Deviation 327
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
48 hours from D38 dose (n=11)
|
263 ng/mL
Standard Deviation 61.4
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
49 hours from D38 dose (n=11)
|
279 ng/mL
Standard Deviation 66.4
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
114 hours from D38 dose (n=11)
|
283 ng/mL
Standard Deviation 112
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
49 hours from D1 dose (n=12)
|
233 ng/mL
Standard Deviation 88.2
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
8 hours from D38 dose (n=11)
|
745 ng/mL
Standard Deviation 239
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
32 hours from D38 dose (n=11)
|
1080 ng/mL
Standard Deviation 328
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
42 hours from D38 dose (n=11)
|
1050 ng/mL
Standard Deviation 340
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dosePopulation: PK Analysis Population; n = number of participants included in the specific dose analysis.
Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants
Days 1 to 5 (n=12)
|
1.75 hours
Standard Deviation 1.14
|
|
Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants
Days 38 to 43 (n=11)
|
1.18 hours
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dosePopulation: PK Analysis Population; n = number of participants included in the specific dose analysis.
Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Tmax of Metabolite Oseltamivir Carboxylate in HD Participants
Days 1 to 5 (n=12)
|
29.7 hours
Standard Deviation 8.0
|
|
Tmax of Metabolite Oseltamivir Carboxylate in HD Participants
Days 38 to 43 (n=11)
|
29.2 hours
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dosePopulation: PK Analysis Population; n = number of participants included in the specific dose analysis.
Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants
Days 1 to 5 (n=12)
|
677 L/h
Standard Deviation 727
|
|
Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants
Days 38 to 43 (n=11)
|
474 L/h
Standard Deviation 141
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dosePopulation: PK Analysis Population; n = number of participants included in the specific dose analysis.
Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CL/F of Metabolite Oseltamivir Carboxylate in HD Participants
Days 1 to 5 (n=12)
|
1.20 L/h
Standard Deviation 1.05
|
|
CL/F of Metabolite Oseltamivir Carboxylate in HD Participants
Days 38 to 43 (n=11)
|
0.779 L/h
Standard Deviation 0.239
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as \[amount of drug excreted divided by the AUC12\]. The CLr was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Renal Clearance (CLr) of Oseltamivir in HD Participants
|
0.0521 L/h
Standard Deviation 0.133
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as \[amount of metabolite excreted divided by the AUC42\]. The CLr was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CLr of Metabolite Oseltamivir Carboxylate in HD Participants
|
0.0203 L/h
Standard Deviation 0.0568
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40Population: PK Analysis Population; n = number of participants included in the specific dose analysis.
Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as \[amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval\]. The CLd with each dose was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants
Days 1 to 5 (n=12)
|
7.42 L/h
Standard Deviation 0.447
|
|
Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants
Days 38 to 43 (n=11)
|
8.43 L/h
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Urine samples 0 to 42 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as \[amount of drug excreted divided by the oral oseltamivir dose\] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants
|
0.00982 percentage of oseltamivir dose
Standard Deviation 0.0221
|
SECONDARY outcome
Timeframe: Urine samples 0 to 42 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as \[amount of metabolite excreted divided by the oral oseltamivir dose\] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants
|
1.86 percentage of osteltamivir dose
Standard Deviation 4.66
|
SECONDARY outcome
Timeframe: Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40Population: PK Analysis Population.
Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 1 hour (Day 3)
|
570 ng/mL
Standard Deviation 229
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 2 hours (Day 3)
|
412 ng/mL
Standard Deviation 157
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 4 hours (Day 3)
|
227 ng/mL
Standard Deviation 82.2
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 5 hours (Day 3)
|
171 ng/mL
Standard Deviation 61.8
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 1 hour (Day 3)
|
284 ng/mL
Standard Deviation 121
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 2 hours (Day 3)
|
202 ng/mL
Standard Deviation 74.4
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 4 hours (Day 3)
|
127 ng/mL
Standard Deviation 69.1
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 5 hours (Day 3)
|
84.3 ng/mL
Standard Deviation 29.6
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 1 hour (Day 40)
|
666 ng/mL
Standard Deviation 179
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 2 hours (Day 40)
|
496 ng/mL
Standard Deviation 125
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 5 hours (Day 40)
|
218 ng/mL
Standard Deviation 45.6
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 1 hour (Day 40)
|
317 ng/mL
Standard Deviation 103
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 2 hours (Day 40)
|
229 ng/mL
Standard Deviation 69.6
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 4 hours (Day 40)
|
128 ng/mL
Standard Deviation 37.3
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Venous: 5 hours (Day 40)
|
95.4 ng/mL
Standard Deviation 27.7
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Arterial: 4 hours (Day 40)
|
281 ng/mL
Standard Deviation 58.8
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dosePopulation: PK Analysis Population.
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
0 hours from D1 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
1 hour from D1 dose
|
27.8 ng/mL
Standard Deviation 21.9
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
2 hours from D1 dose
|
22.6 ng/mL
Standard Deviation 12.6
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
4 hours from D1 dose
|
6.98 ng/mL
Standard Deviation 2.70
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
8 hours from D1 dose
|
0.630 ng/mL
Standard Deviation 0.833
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
12 hours from D1 dose
|
0.100 ng/mL
Standard Deviation 0.346
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
24 hours from D1 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
48 hours from D1 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
72 hours from D1 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
120 hours from D1 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
1 hour from D36 dose
|
24.8 ng/mL
Standard Deviation 16.8
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
2 hours from D36 dose
|
18.0 ng/mL
Standard Deviation 8.88
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
4 hours from D36 dose
|
5.78 ng/mL
Standard Deviation 2.09
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
8 hours from D36 dose
|
0.754 ng/mL
Standard Deviation 0.705
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
12 hours from D36 dose
|
0.103 ng/mL
Standard Deviation 0.358
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
24 hours from D36 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
48 hours from D36 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
72 hours from D36 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
120 hours from D36 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
168 hours from D36 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
0 hours from D36 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dosePopulation: PK Analysis Population.
Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
0 hours from D1 dose
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
1 hour from D1 dose
|
20.3 ng/mL
Standard Deviation 19.9
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
2 hours from D1 dose
|
121 ng/mL
Standard Deviation 72.7
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
4 hours from D1 dose
|
381 ng/mL
Standard Deviation 171
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
8 hours from D1 dose
|
691 ng/mL
Standard Deviation 217
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
12 hours from D1 dose
|
812 ng/mL
Standard Deviation 251
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
24 hours from D1 dose
|
879 ng/mL
Standard Deviation 245
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
72 hours from D1 dose
|
360 ng/mL
Standard Deviation 148
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
120 hours from D1 dose
|
147 ng/mL
Standard Deviation 80.9
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
0 hours from D36 dose
|
69.2 ng/mL
Standard Deviation 40.1
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
1 hour from D36 dose
|
97.0 ng/mL
Standard Deviation 52.3
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
2 hours from D36 dose
|
184 ng/mL
Standard Deviation 84.7
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
4 hours from D36 dose
|
403 ng/mL
Standard Deviation 149
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
8 hours from D36 dose
|
663 ng/mL
Standard Deviation 179
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
12 hours from D36 dose
|
802 ng/mL
Standard Deviation 200
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
24 hours from D36 dose
|
831 ng/mL
Standard Deviation 201
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
48 hours from D36 dose
|
563 ng/mL
Standard Deviation 172
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
72 hours from D36 dose
|
362 ng/mL
Standard Deviation 138
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
120 hours from D36 dose
|
149 ng/mL
Standard Deviation 71.6
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
168 hours from D36 dose
|
63.0 ng/mL
Standard Deviation 38.1
|
|
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
48 hours from D1 dose
|
580 ng/mL
Standard Deviation 193
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dosePopulation: PK Analysis Population.
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Tmax of Oseltamivir in CAPD Participants
Days 1 to 6
|
1.50 hours
Standard Deviation 0.52
|
|
Tmax of Oseltamivir in CAPD Participants
Days 36 to 43
|
1.28 hours
Standard Deviation 0.0470
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dosePopulation: PK Analysis Population.
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 1 to 6
|
20.0 hours
Standard Deviation 5.91
|
|
Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 36 to 43
|
19.0 hours
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population.
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as \[natural log (ln)(2) divided by the half-life\] and expressed as inverse hours (1/h).
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 1 to 6
|
0.0211 1/h
Standard Deviation 0.00578
|
|
Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 36 to 43
|
0.0200 1/h
Standard Deviation 0.00488
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population.
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 1 to 6
|
34.8 hours
Standard Deviation 8.39
|
|
Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 36 to 43
|
36.3 hours
Standard Deviation 7.53
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dosePopulation: PK Analysis Population.
Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CL/F of Oseltamivir in CAPD Participants
Days 1 to 6
|
424 L/h
Standard Deviation 183
|
|
CL/F of Oseltamivir in CAPD Participants
Days 36 to 43
|
485 L/h
Standard Deviation 215
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dosePopulation: PK Analysis Population.
Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 1 to 6
|
0.882 L/h
Standard Deviation 0.250
|
|
CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants
Days 36 to 43
|
0.898 L/h
Standard Deviation 0.246
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as \[amount of drug excreted divided by the AUC12\]. The CLr was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CLr of Oseltamivir in CAPD Participants
|
0.146 L/h
Standard Deviation 0.250
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as \[amount of metabolite excreted divided by the AUC48\]. The CLr was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants
|
0.0665 L/h
Standard Deviation 0.114
|
SECONDARY outcome
Timeframe: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as \[amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval\]. The CLd was averaged among all participants and expressed in L/h.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants
|
0.425 L/h
Standard Deviation 0.0456
|
SECONDARY outcome
Timeframe: Urine samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as \[amount of drug in urine divided by the oral oseltamivir dose\] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants
|
0.0290 percentage of oseltamivir dose
Standard Deviation 0.0490
|
SECONDARY outcome
Timeframe: Urine samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as \[amount of metabolite in urine divided by the oral oseltamivir dose\] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants
|
6.44 percentage of oseltamivir dose
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Dialysate samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as \[amount of drug in dialysate divided by the oral oseltamivir dose\] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants
|
0.00367 percentage of oseltamivir dose
Standard Deviation 0.0127
|
SECONDARY outcome
Timeframe: Dialysate samples 0 to 48 hours from D1 dosePopulation: PK Analysis Population (First Dose Subpopulation).
Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as \[amount of metabolite in dialysate divided by the oral oseltamivir dose\] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Outcome measures
| Measure |
Oseltamivir With HD
n=12 Participants
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
|---|---|
|
Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants
|
32.6 percentage of oseltamivir dose
Standard Deviation 8.77
|
Adverse Events
Oseltamivir With HD
Oseltamivir With CAPD
Serious adverse events
| Measure |
Oseltamivir With HD
n=12 participants at risk
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
Oseltamivir With CAPD
n=12 participants at risk
Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Cardiac disorders
Pericarditis not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
Other adverse events
| Measure |
Oseltamivir With HD
n=12 participants at risk
Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
|
Oseltamivir With CAPD
n=12 participants at risk
Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting not otherwise specified
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
25.0%
3/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
25.0%
3/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea not otherwise specified
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
General disorders
Dizziness (excluding vertigo)
|
16.7%
2/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
General disorders
Malaise
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
16.7%
2/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
General disorders
Fatigue
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
General disorders
Haemorrhage not otherwise specified
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
General disorders
Injection site pain
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
General disorders
Pain in jaw
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Nervous system disorders
Headache not otherwise specified
|
33.3%
4/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
33.3%
4/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
16.7%
2/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Metabolism and nutrition disorders
Appetite decreased
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Metabolism and nutrition disorders
Calcification metastatic
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Metabolism and nutrition disorders
Gout
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin disorder not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Tongue oedema
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat not otherwise specified
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Infections and infestations
Blood culture positive
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Infections and infestations
Urinary tract infection not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Infections and infestations
Vaginitis
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Infections and infestations
Vaginosis bacterial not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia not otherwise specified, aggravated
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Hepatobiliary disorders
Hepatic function abnormal not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Injury, poisoning and procedural complications
Skin injury not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Psychiatric disorders
Depression not otherwise specified
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
0.00%
0/12 • From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Safety Population
|
Additional Information
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