drugset / Trial / NCT02781844

Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism

NCT02781844

Phase 1 Completed 34 enrolled Shire
RandomizedCrossoverOpen-labelTreatment

Summary

This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara® and in the EU as Natpar).

Timeline

Start
2017-04-03
Primary completion
2019-03-08
Completion
2019-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Parathyroid Hormone Protein / enzyme biologic 25 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 50 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 100 ug Subcutaneous

Indications