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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01556633




Registration number
NCT01556633
Ethics application status
Date submitted
15/03/2012
Date registered
16/03/2012
Date last updated
7/07/2016

Titles & IDs
Public title
A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance
Scientific title
An Open Label, Prospective, Single Oral Dose Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Oseltamivir in Adult Subjects on Peritoneal Dialysis (PD) Using a Rapid Cycle Regimen to Simulate APD and in Adult Subjects With Creatinine Clearance From 10 to 30 mL/Min Not on Dialysis
Secondary ID [1] 0 0
NV25655
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tamiflu (oseltamivir)
Treatment: Drugs - Tamiflu (oseltamivir)

Experimental: Volunteers on dialysis -

Experimental: Volunteers with reduced creatinine clearance -


Treatment: Drugs: Tamiflu (oseltamivir)
Single dose of Tamiflu in volunteers on dialysis

Treatment: Drugs: Tamiflu (oseltamivir)
Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Timepoint [1] 0 0
CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood
Primary outcome [2] 0 0
AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Timepoint [2] 0 0
Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Primary outcome [3] 0 0
AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose
Timepoint [3] 0 0
Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Primary outcome [4] 0 0
Cmax of Oseltamivir and Oseltamivir Carboxylate
Timepoint [4] 0 0
Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Primary outcome [5] 0 0
C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Timepoint [5] 0 0
Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Primary outcome [6] 0 0
Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate
Timepoint [6] 0 0
Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Primary outcome [7] 0 0
Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate
Timepoint [7] 0 0
Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.
Secondary outcome [1] 0 0
Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Approximately 7 weeks
Secondary outcome [2] 0 0
Number of Participants With Marked Abnormality in Laboratory Measurements
Timepoint [2] 0 0
Approximately 7 weeks
Secondary outcome [3] 0 0
Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
Timepoint [3] 0 0
From Baseline (Day -1) to Follow-up visit (Days 15 to 22)
Secondary outcome [4] 0 0
Number of Participants With Abnormal Shifts in Vital Signs
Timepoint [4] 0 0
Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)

Eligibility
Key inclusion criteria
General

* Adult volunteers, aged 19 to 90 years
* Medically stable with no hospitalization for a significant disease in the 3 months before study start

Volunteers on dialysis

* A documented and well-established dialysis therapy

Volunteers with reduced creatinine clearance

* Creatinine clearance from 10 to 30 mL/min
* Stable renal function
Minimum age
19 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Clinically significant and unstable disease (e.g., cardiac, hepatic, pulmonary)
* Medical history of concurrent medical condition that would compromise participation in the study
* Hypotensive episodes or symptoms of fainting, dizziness or lightheadedness in the 4 weeks before screening
* Uncontrolled hypotension or hypertension
* Infection with hepatitis B, hepatitis C or human immunodeficiency virus

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.
Trial website
https://clinicaltrials.gov/study/NCT01556633
Trial related presentations / publications
Patel K, Rayner CR, Giraudon M, Kamal MA, Morcos PN, Robson R, Kirkpatrick CM. Pharmacokinetics and safety of oseltamivir in patients with end-stage renal disease treated with automated peritoneal dialysis. Br J Clin Pharmacol. 2015 Apr;79(4):624-35. doi: 10.1111/bcp.12526.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01556633