drugset / Trial / NCT02206087

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin

NCT02206087 ↗

Phase 1/2 Completed 60 enrolled AMAG Pharmaceuticals, Inc.
RandomizedSequentialSingle-blindOther

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.

Timeline

Start
2014-06
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciraparantag Small molecule 100 mg —
Subject Ciraparantag Small molecule 200 mg —
Subject Ciraparantag Small molecule 300 mg —
Subject Ciraparantag Small molecule 400 mg —
Subject Ciraparantag Small molecule 500 mg —
Subject Ciraparantag Small molecule 600 mg —
Background Heparin Other / unclassified — —

Indications

No indication recorded.