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This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cross-over treatment with increasing doses of PTH134, placebo and active comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTH134 | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| •Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| •Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG, Basel | Novartis Pharma AG, Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22289659 | Derived | Hammerle SP, Mindeholm L, Launonen A, Kiese B, Loeffler R, Harfst E, Azria M, Arnold M, John MR. The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women. Bone. 2012 Apr;50(4):965-73. doi: 10.1016/j.bone.2012.01.009. Epub 2012 Jan 25. |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |