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NCT01826266 · ClinicalTrials.gov registry record · Phase 1
Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban
A Phase 1 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT01826266: Completed Phase 1 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
NCT01826266 is a Phase 1 study that has completed, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals. The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01826266, a Phase 1 study, has completed, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time \[PoC-PT\]), and/or secondary biomarkers (thromboelastography reaction time \[TEG-R\]) will be identified.
Interventions
- DRUG PER977, Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals9 total trials
What the finished NCT01826266 record still lists
NCT01826266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 1 intervention - of which PER977, Placebo is the first listed.
NCT01826266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01826266 about?
NCT01826266 is a clinical study titled "Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban". PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time \[PoC-PT...
What is the current status of trial NCT01826266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2013-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01826266?
The interventions under investigation include: PER977, Placebo (DRUG).
Who is sponsoring clinical trial NCT01826266?
This trial is sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01826266's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 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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