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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |