A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Adults greater than or equal to (>/=) 18 years of age

• ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than (<) 10 milliliters per minute (mL/min)

• Well established HD or CAPD therapy over a period of 3 months with stable CrCl < 10 mL/min

• Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m^2)

• Use of contraception among women of childbearing potential

Exclusion Criteria:

• Clinical significant comorbid disease or terminal illness

• Known human immunodeficiency virus (HIV) or hepatitis B or C

• History of drug or alcohol abuse within the prior year

• Donation or loss of >/= 400 milliliters (mL) of blood in the 3 months prior to Screening

• Participation in a clinical study with an investigational drug in the 3 months prior to study drug

• Pregnant or lactating women