This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.
Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3
Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5
Time frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2
Time frame: Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3
Time frame: Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4
Time frame: Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
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Unnamed facility
Los Angeles, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Wilmington, Delaware, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
South Bend, Indiana, United States
Unnamed facility
Wichita, Kansas, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Boston, Massachusetts, United States
...and 28 more locations
Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5
Time frame: Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate
Time frame: Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values
IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either \>=5 times change in the NAI IC50 visit value from the Reference value at a visit, \>=5 times change in the NAI IC50 Visit value from the Baseline value.
Time frame: Baseline, Day 1, 6 and 30