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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. 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.
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
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02206087
The ClinicalTrials.gov registry entry for NCT02206087 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02206087 reports 0 study locations.
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.
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