Phase 1 N=16 Treatment

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

Healthy Volunteer

Bottom Line

View on ClinicalTrials.gov: NCT01556633 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Jul 2016

Primary outcome: Primary: Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose — NA; NA; 0.183; 0.230 Litre (L)/hour (h)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Tamiflu (oseltamivir) (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose	NA; NA; 0.183; 0.230; 0.187; 0.326	—
PRIMARY AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose	175; 175; 175; 83400; 89200; 93800	—
PRIMARY AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose	64.7; 8630	—
PRIMARY Cmax of Oseltamivir and Oseltamivir Carboxylate	67.1; 22.1; 1710; 361	—
PRIMARY C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose	NA; NA; 1.30; 301.0; 138.0; 140.0	—
PRIMARY Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate	2.50; 1.33; 1.92; 2.25; 20.00; 7.34	—
PRIMARY Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate	0.572; 3.30; 0.655; 2.28	—
SECONDARY Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)	9; 2; 1; 0	—
SECONDARY Number of Participants With Marked Abnormality in Laboratory Measurements	1; 0; 3; 0; 3; 0	—
SECONDARY Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit	8; 6; 2; 0; 10; 6	—
SECONDARY Number of Participants With Abnormal Shifts in Vital Signs	1; 0; 2; 1; 2; 1	—

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01556633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.