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: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, prospective, single dose study will evaluate the pharmacokineti cs and safety of Tamiflu (oseltamivir) in volunteers on dialysis and in voluntee rs with a creatinine clearance from 10 to 30 mL/min. Volunteers will receive a s ingle 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 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 September 18, 2014