Phase 1
Completed N=24
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Source: ClinicalTrials.gov NCT02617784 ↗Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Feb 2016
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 — 20.2 ng/mL
Summary
This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 |
20.2 | — |
| PRIMARY Cmax of Oseltamivir in HD Participants During Days 38 to 43 |
22.6 | — |
| PRIMARY Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 |
943 | — |
| PRIMARY Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 |
1120 | — |
| PRIMARY Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5 |
63.9; 62.1 | — |
| PRIMARY AUC of Oseltamivir in HD Participants During Days 38 to 43 |
68.5; 65.6 | — |
| PRIMARY AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 |
31600; 44400 | — |
| PRIMARY AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 |
38200; 60400 | — |
| PRIMARY Cmax of Oseltamivir in CAPD Participants During Days 1 to 6 |
32.0 | — |
| PRIMARY Cmax of Oseltamivir in CAPD Participants During Days 36 to 43 |
27.7 | — |
| PRIMARY Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 |
885 | — |
| PRIMARY Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 |
849 | — |
| PRIMARY AUC of Oseltamivir in CAPD Participants During Days 1 to 6 |
85.6; 78.5 | — |
| PRIMARY AUC of Oseltamivir in CAPD Participants During Days 36 to 43 |
72.4; 67.7 | — |
| PRIMARY AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 |
33400; 56800 | — |
| PRIMARY AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 |
32400; 60800 | — |
| SECONDARY Plasma Concentration of Oseltamivir by Timepoint in HD Participants |
0; 18.0; 12.5; 6.06; 1.93; 0.513 | — |
| SECONDARY Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants |
0.908; 25.7; 107; 276; 589; 772 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants |
1.75; 1.18 | — |
| SECONDARY Tmax of Metabolite Oseltamivir Carboxylate in HD Participants |
29.7; 29.2 | — |
| SECONDARY Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants |
677; 474 | — |
| SECONDARY CL/F of Metabolite Oseltamivir Carboxylate in HD Participants |
1.20; 0.779 | — |
| SECONDARY Renal Clearance (CLr) of Oseltamivir in HD Participants |
0.0521 | — |
| SECONDARY CLr of Metabolite Oseltamivir Carboxylate in HD Participants |
0.0203 | — |
| SECONDARY Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants |
7.42; 8.43 | — |
| SECONDARY Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants |
0.00982 | — |
| SECONDARY Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants |
1.86 | — |
| SECONDARY Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants |
570; 412; 227; 171; 284; 202 | — |
| SECONDARY Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants |
0.0; 27.8; 22.6; 6.98; 0.630; 0.100 | — |
| SECONDARY Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants |
0.0; 20.3; 121; 381; 691; 812 | — |
| SECONDARY Tmax of Oseltamivir in CAPD Participants |
1.50; 1.28 | — |
| SECONDARY Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants |
20.0; 19.0 | — |
| SECONDARY Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants |
0.0211; 0.0200 | — |
| SECONDARY Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants |
34.8; 36.3 | — |
| SECONDARY CL/F of Oseltamivir in CAPD Participants |
424; 485 | — |
| SECONDARY CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants |
0.882; 0.898 | — |
| SECONDARY CLr of Oseltamivir in CAPD Participants |
0.146 | — |
| SECONDARY CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants |
0.0665 | — |
| SECONDARY CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants |
0.425 | — |
| SECONDARY Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants |
0.0290 | — |
| SECONDARY Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants |
6.44 | — |
| SECONDARY Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants |
0.00367 | — |
| SECONDARY Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants |
32.6 | — |
Eligibility Criteria
Inclusion Criteria
- Adults greater than or equal to (>/=) 18 years of age
- ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than ( /= 400 milliliters (mL) of blood in the 3 months prior to Screening
- Participation in a clinical study with an investigational drug in the 3 months prior to study drug
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02617784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.