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The purpose of this trial is to determine the safety and tolerability of ascending single and multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 SAD | Active Comparator | four diffferent doses |
|
| Part 2a MAD | Placebo Comparator | three doses |
|
| Part 2b | Active Comparator | 0.24 mg LEO 27847 |
|
| Part 2c | Active Comparator | 0.24 mg LEO 27847 |
|
| Parat 2a MAD | Placebo Comparator | one dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 27847 | Drug | First in patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Adverse events, vital signs, ECG, laboratory evaluation, physical examination | 7 days after last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics and Pharmacodynamics | LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine | 7 days after last dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany | |||
| Centralny Szpital Kliniczny MON |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Warsaw |
| 04-141 |
| Poland |