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.