A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01556633
First received: March 15, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: Tamiflu (oseltamivir)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics (Area under the concentration time curve) [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Volunteers on dialysis Drug: Tamiflu (oseltamivir)
Single dose of Tamiflu in volunteers on dialysis
Experimental: Volunteers with reduced creatinine clearance Drug: Tamiflu (oseltamivir)
Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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 epsiodes 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556633

Locations
New Zealand
Christchurch, New Zealand, 8011
Grafton, New Zealand, 1010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01556633     History of Changes
Other Study ID Numbers: NV25655
Study First Received: March 15, 2012
Last Updated: April 7, 2014
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014