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

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ClinicalTrials.gov Identifier: NCT02617784
Recruitment Status : Completed
First Posted : December 1, 2015
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 27, 2015
First Posted Date  ICMJE December 1, 2015
Results First Submitted Date  ICMJE January 17, 2016
Results First Posted Date  ICMJE February 15, 2016
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE October 2001
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2016)
  • Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose ]
    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).
  • Cmax of Oseltamivir in HD Participants During Days 38 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose ]
    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.
  • Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose ]
    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.
  • Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose ]
    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.
  • Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose ]
    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).
  • AUC of Oseltamivir in HD Participants During Days 38 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose ]
    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.
  • AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose ]
    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.
  • AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose ]
    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.
  • Cmax of Oseltamivir in CAPD Participants During Days 1 to 6 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose ]
    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.
  • Cmax of Oseltamivir in CAPD Participants During Days 36 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose ]
    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.
  • Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose ]
    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.
  • Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose ]
    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.
  • AUC of Oseltamivir in CAPD Participants During Days 1 to 6 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose ]
    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.
  • AUC of Oseltamivir in CAPD Participants During Days 36 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose ]
    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.
  • AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose ]
    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.
  • AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2015)
  • Cmax of metabolite oseltamivir carboxylate in participants on HD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, and 90 hours post-dose on Days 1 and 38 ]
  • Cmax of metabolite oseltamivir carboxylate in participants on CAPD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 24, 48, 72, 120, and 168 hours post-dose on Days 1 and 36 ]
  • Area under the concentration-time curve (AUC) of oseltamivir in participants on HD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, and 90 hours post-dose on Days 1 and 38 ]
  • AUC of oseltamivir in participants on CAPD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 24, 48, 72, 120, and 168 hours post-dose on Days 1 and 36 ]
  • AUC of metabolite oseltamivir carboxylate in participants on HD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, and 90 hours post-dose on Days 1 and 38 ]
  • AUC of metabolite oseltamivir carboxylate in participants on CAPD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 24, 48, 72, 120, and 168 hours post-dose on Days 1 and 36 ]
  • Cmax of oseltamivir in participants on CAPD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 24, 48, 72, 120, and 168 hours post-dose on Days 1 and 36 ]
  • Maximum plasma concentration (Cmax) of oseltamivir in participants on HD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, and 90 hours post-dose on Days 1 and 38 ]
Change History Complete list of historical versions of study NCT02617784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2016)
  • Plasma Concentration of Oseltamivir by Timepoint in HD Participants [ Time Frame: 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 ]
    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.
  • Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants [ Time Frame: 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 ]
    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.
  • Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose ]
    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.
  • Tmax of Metabolite Oseltamivir Carboxylate in HD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose ]
    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.
  • Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose ]
    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).
  • CL/F of Metabolite Oseltamivir Carboxylate in HD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose ]
    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.
  • Renal Clearance (CLr) of Oseltamivir in HD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose ]
    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.
  • CLr of Metabolite Oseltamivir Carboxylate in HD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose ]
    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.
  • Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants [ Time Frame: 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 ]
    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.
  • Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants [ Time Frame: Urine samples 0 to 42 hours from D1 dose ]
    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.
  • Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants [ Time Frame: Urine samples 0 to 42 hours from D1 dose ]
    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.
  • Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants [ Time Frame: Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40 ]
    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.
  • Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants [ Time Frame: 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 ]
    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.
  • Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants [ Time Frame: 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 ]
    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.
  • Tmax of Oseltamivir in CAPD Participants [ Time Frame: 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 ]
    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.
  • Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: 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 ]
    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.
  • Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: 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 ]
    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).
  • Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: 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 ]
    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.
  • CL/F of Oseltamivir in CAPD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose ]
    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.
  • CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose ]
    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.
  • CLr of Oseltamivir in CAPD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose ]
    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.
  • CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose ]
    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.
  • CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: 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 ]
    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.
  • Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants [ Time Frame: Urine samples 0 to 48 hours from D1 dose ]
    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.
  • Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: Urine samples 0 to 48 hours from D1 dose ]
    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.
  • Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants [ Time Frame: Dialysate samples 0 to 48 hours from D1 dose ]
    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.
  • Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants [ Time Frame: Dialysate samples 0 to 48 hours from D1 dose ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2015)
  • Time to maximum plasma concentration (Tmax) of oseltamivir in participants on HD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, and 90 hours post-dose on Days 1 and 38 ]
  • Tmax of metabolite oseltamivir carboxylate in participants on HD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, and 90 hours post-dose on Days 1 and 38 ]
  • Tmax of oseltamivir in participants on CAPD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 24, 48, 72, 120, and 168 hours post-dose on Days 1 and 36 ]
  • Tmax of metabolite oseltamivir carboxylate in participants on CAPD [ Time Frame: Blood PK samples pre-dose and 1, 2, 4, 8, 12, 24, 48, 72, 120, and 168 hours post-dose on Days 1 and 36 ]
  • Percentage of participants with adverse events (AEs) [ Time Frame: Up to 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE Drug: Oseltamivir
Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.
Other Name: Tamiflu
Study Arms  ICMJE
  • Experimental: Regimen A: Oseltamivir with HD
    Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir.
    Intervention: Drug: Oseltamivir
  • Experimental: Regimen B: Oseltamivir with CAPD
    Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.
    Intervention: Drug: Oseltamivir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2015)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2002
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02617784
Other Study ID Numbers  ICMJE NP16472
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP