Phase 1
N=8
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01033734 ↗Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Aug 2016
Primary outcome: Primary: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1 — 829; 1460; 1700; 4550 hour*nanogram/milliliter (h*ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- oseltamivir [Tamiflu] (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1 |
829; 1460; 1700; 4550 | — |
| PRIMARY AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2 |
1070; 1920; 5970; 6760 | — |
| PRIMARY AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3 |
943; 2000 | — |
| PRIMARY AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4 |
2480; 3800 | — |
| PRIMARY AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5 |
1010; 2820 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1 |
360; 753; 311; 499 | — |
| PRIMARY Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2 |
500; 1270; 663; 725 | — |
| PRIMARY Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3 |
404; 237 | — |
| PRIMARY Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4 |
915; 549 | — |
| PRIMARY Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5 |
403; 408 | — |
| SECONDARY Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate |
2.00; 1.26; NA; 4.00; 4.61; NA | — |
| SECONDARY Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate |
4.40; 2.41; NA; 237; 308; NA | — |
| SECONDARY Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate |
7.42; 10.50; NA; 7.42; 11.98; NA | — |
| SECONDARY Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate |
— | — |
| SECONDARY Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate |
— | — |
| SECONDARY Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate |
— | — |
| SECONDARY Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values |
1; 0; 1; 0; 1; NA | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- children, 1-12 years of age
- diagnosis of influenza
- duration of influenza symptoms </=96 hours prior to first dose of study drug
Exclusion Criteria
- evidence of severe hepatic decompensation
- patients taking probenecid within 1 week prior to first dose of study drug
Data sourced from ClinicalTrials.gov (NCT01033734). 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.