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

NCT03516773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-26

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Entera Bio Ltd.

    lead INDUSTRY

Principal Investigators

  • Arthur Santora, MD · Entera Bio Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-17
Primary Completion
2018-12-05
Completion
2019-02-24

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516773 on ClinicalTrials.gov