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NCT02717754 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT02717754: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02717754 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02717754, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study 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.
Primary Outcome
AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Interventions
- DRUG Placebo
- DRUG Oseltamivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT02717754 record still lists
NCT02717754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02717754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02717754 about?
NCT02717754 is a clinical study titled "A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants". 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, 2...
What is the current status of trial NCT02717754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2009-12. Estimated completion is 2010-05.
What interventions are being tested in trial NCT02717754?
The interventions under investigation include: Placebo (DRUG), Oseltamivir (DRUG).
Who is sponsoring clinical trial NCT02717754?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02717754's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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