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NCT02206087 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin
A Phase 1 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02206087: Completed Phase 1 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
NCT02206087 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 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02206087, 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
- 60 participants
- Enrollment target
Study Summary
Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and then will receive unfractionated heparin followed by a single dose of PER977. The study will provide some insight into the doses that may be required to reverse anticoagulation induced by heparin.
Primary Outcome
To identify a dose of PER977 that reverses the effects of heparin as measured by whole blood clotting time
Interventions
- DRUG Placebo
- DRUG PER977
- DRUG Heparin Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals9 total trials
What the finished NCT02206087 record still lists
NCT02206087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02206087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02206087 about?
NCT02206087 is a clinical study titled "Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin". Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and then will receive unfractionated heparin followed by a single dose of PER9...
What is the current status of trial NCT02206087?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2014-06. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02206087?
The interventions under investigation include: Placebo (DRUG), PER977 (DRUG), Heparin Sodium (DRUG).
Who is sponsoring clinical trial NCT02206087?
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 NCT02206087's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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