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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556633
• Other study ID #: NV25655
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2012
• Last updated: October 1, 2015
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Tamiflu (oseltamivir)
Single dose of Tamiflu in volunteers on dialysis
• Tamiflu (oseltamivir)
Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (Area under the concentration time curve)		Days 1, 2, 3, 4, 5, 6, 7, 8	No
Secondary	Safety (Incidence of adverse events)		Approximately 1 month	No