Clinical trial NCT02617784: A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Official title: A Single Center, Open Label, Multiple-Dose Oral Oseltamivir Suspension Study in End-Stage-Renal Disease (ESRD) Patients on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (\<) 10 milliliters per minute (mL/min)
* Well established HD or CAPD therapy over a period of 3 months with stable CrCl \< 10 mL/min
* Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m\^2)
* Use of contraception among women of childbearing potential

Exclusion Criteria:

* Clinical significant comorbid disease or terminal illness
* Known human immunodeficiency virus (HIV) or hepatitis B or C
* History of drug or alcohol abuse within the prior year
* Donation or loss of \>/= 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose
measure: Cmax of Oseltamivir in HD Participants During Days 38 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose
measure: Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
measure: Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
measure: Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
measure: AUC of Oseltamivir in HD Participants During Days 38 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
measure: AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
measure: AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
measure: Cmax of Oseltamivir in CAPD Participants During Days 1 to 6
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
measure: Cmax of Oseltamivir in CAPD Participants During Days 36 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose
measure: Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
measure: Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
measure: AUC of Oseltamivir in CAPD Participants During Days 1 to 6
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
measure: AUC of Oseltamivir in CAPD Participants During Days 36 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
measure: AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
measure: AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
Secondary outcomes:
measure: Plasma Concentration of Oseltamivir by Timepoint in HD Participants
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 dose
measure: Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
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 dose
measure: Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose
measure: Tmax of Metabolite Oseltamivir Carboxylate in HD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose
measure: Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose
measure: CL/F of Metabolite Oseltamivir Carboxylate in HD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose
measure: Renal Clearance (CLr) of Oseltamivir in HD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose
measure: CLr of Metabolite Oseltamivir Carboxylate in HD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose
measure: Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants
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 40
measure: Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants
timeFrame: Urine samples 0 to 42 hours from D1 dose
measure: Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants
timeFrame: Urine samples 0 to 42 hours from D1 dose
measure: Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
timeFrame: Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40
measure: Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
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
measure: Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
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
measure: Tmax of Oseltamivir in CAPD Participants
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
measure: Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants
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
measure: Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants
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 dose
measure: Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants
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 dose
measure: CL/F of Oseltamivir in CAPD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose
measure: CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose
measure: CLr of Oseltamivir in CAPD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose
measure: CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants
timeFrame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose
measure: CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants
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 dose
measure: Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants
timeFrame: Urine samples 0 to 48 hours from D1 dose
measure: Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants
timeFrame: Urine samples 0 to 48 hours from D1 dose
measure: Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants
timeFrame: Dialysate samples 0 to 48 hours from D1 dose
measure: Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants
timeFrame: Dialysate samples 0 to 48 hours from D1 dose
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: