NCT03516773

Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism

An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Parathyroid Hormone [PTH (1-34)] and NATPARA® in Patients With Hypoparathyroidism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Entera Bio Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, active comparator, two-part, partial crossover design. The study is designed to assess the pharmacokinetics and pharmacodynamics of EnteraBio's Oral PTH(1-34) \[EB612 (EBP05)\] in adult patients with hypoparathyroidism.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	EB612 (EBP05)	Entera Bio's proprietary drug for the administration of PTH(1-34) orally
DRUG	NATPARA/NATPAR	A PTH replacement (PTH \[1-84\]; NATPARA (Shire-NPS Pharmaceuticals, Inc., Lexington, Massachusetts) was approved by the United States (US) Food and Drug Administration (FDA) in April 2015 / NATPAR (Shire Pharmaceuticals Ltd., Dublin, Ireland) was approved by the European Medicines Agency in April 2017 for use as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Like many other hormonally active peptides, PTH (1 84); NATPARA is parenterally administered. In this protocol when a specific formulation is referenced (e.g. NATPARA) it may be read interchanged with the alternate formulation (e.g. NATPAR).

Timeline

• Start date: 2018-06-17
• Primary completion: 2018-12-05
• Completion: 2019-02-24
• First posted: 2018-05-04
• Last updated: 2019-03-26

Locations

1 site across 1 country: Israel