CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 99 enrolled
Drug / intervention
Oseltamivir +1 moredrug
Likely dose
Oseltamivir 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02717754
NCT02717754Phase 1Completed
CompareCT.gov

A Multiple-Center, Randomized, Double-blind, Multiple-Dose, Placebo-Controlled, Parallel-Group Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO0640796 (Oseltamivir) and Its Carboxylate Metabolite, RO0640802, Following Intravenous Administrations in Healthy Subjects

Hoffmann-La Roche·interventional·Posted Mar 24, 2016·Updated Jun 27, 2016

In Brief

A Phase 1 clinical trial evaluating Oseltamivir and Placebo for Healthy Volunteer. Completed, enrolled 99 participants across 2 sites.

Detailed Summary

This multi-center, randomized, double-blind, multiple-dose, placebo-controlled, parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered intravenously twice daily (BID). The anticipated time on study treatment is 5 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2016
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.3 years ago

Interventions

Oseltamivirdrug

Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.

Placebodrug

Oseltamivir matched placebo will be administered intravenous for 5 days.