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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Tamiflu (oseltamivir)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01556633

NV25655

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Volunteers on dialysis

Experimental group

Treatment:

Drug: Tamiflu (oseltamivir)

Drug: Tamiflu (oseltamivir)

Volunteers with reduced creatinine clearance

Experimental group

Treatment:

Drug: Tamiflu (oseltamivir)

Drug: Tamiflu (oseltamivir)