Phase 1 N=24 Treatment

A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT02617784 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Feb 2016

Primary outcome: Primary: Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 — 20.2 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Oseltamivir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jun 2002

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	—

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.

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

View full record on ClinicalTrials.gov →

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.