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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 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 |
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| Treatment B | Experimental | 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 |
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| Treatment C | Active Comparator | Intervention: NATPARA/NATPAR PTH(1-84) 100 μg subcutaneous injection once daily (single dose) |
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| Treatment D | Experimental | 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 |
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| Treatment E - EB612 (EBP05) | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EB612 (EBP05) | Drug | Entera Bio's proprietary drug for the administration of PTH(1-34) orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma PTH(1-34) levels | Pharmacokinetic Parameter | 18 weeks |
| Serum albumin-adjusted total calcium levels | Pharmacodynamic Parameter | 18 weeks |
| urinary calcium levels | Pharmacodynamic Parameter | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety Parameter | 60 days |
| Rate of Adverse Events leading to discontinuation | Tolerability Parameter | 60 days |
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-Criteria for Inclusion:
Criteria for Exclusion:
Childbearing potential is defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal. Women will be defined as postmenopausal if they have been amenorrheic for 12 months (prior to signature of Informed Consent Form) without an alternative medical cause.
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Santora, MD | Entera Bio Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center Hadassah Ein Kerem Medical Center | Jerusalem | 91120, | Israel |
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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Randomized, active comparator, two-part, within-part, partial crossover design.
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| NATPARA/NATPAR | Drug | 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). |
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| D000602 | Amino Acids, Peptides, and Proteins |