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

Phase 2

Completed

• Conditions: Hypoparathyroidism
• Interventions: Drug: EB612 (EBP05); Drug: NATPARA/NATPAR

• Registration Number: NCT03516773
• Lead Sponsor: Entera Bio Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-04
• Study Start: 2018-06-17
• Primary Completion: 2018-12-05
• Study Completion: 2019-02-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	EB612 (EBP05)	Intervention: EB612 (EBP05) 2.25 mg orally (PO) four times a day (QID) (approximately 5 hours apart) for 4 doses, for a total dose of 9 mg per day
Treatment B	EB612 (EBP05)	Intervention: EB612 (EBP05) 2.25 mg PO twice a day (BID) (approximately 10 hours apart) for 2 doses, for a total dose of 4.5 mg per day
Treatment C	NATPARA/NATPAR	Intervention: NATPARA/NATPAR PTH(1-84) 100 μg subcutaneous injection once daily (single dose)
Treatment D	EB612 (EBP05)	Intervention: EB612 (EBP05) 2.25 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 6.75 mg per day
Treatment E - EB612 (EBP05)	EB612 (EBP05)	Intervention: EB612 (EBP05) 0.75 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 2.25 mg per day

Primary Outcome Measures

Name	Time	Method
Plasma PTH(1-34) levels	18 weeks	Pharmacokinetic Parameter
Serum albumin-adjusted total calcium levels	18 weeks	Pharmacodynamic Parameter
urinary calcium levels	18 weeks	Pharmacodynamic Parameter

Secondary Outcome Measures

Name	Time	Method
Adverse Events	60 days	Safety Parameter
Rate of Adverse Events leading to discontinuation	60 days	Tolerability Parameter

Trial Locations

Locations (1)

Clinical Research Center Hadassah Ein Kerem Medical Center; 🇮🇱 Jerusalem, Israel