LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients

Study Overview
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Brief Summary
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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.

Official Title
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LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: LEO 27847


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 75 years (inclusive) at screening. Patients with body mass index within 18 to 34 kg/m2 (inclusive). Haemoglobin is stable (≥9 g/dL or 5.6 mmol/L) Parathyroid hormone (PTH) is ≥200 pg/mL and <800 pg/mL. Screening serum albumin is ≥30 g/L. C-reactive protein <25 mg/L. Exclusion Criteria: Adjustment of vitamin D sterols within 14 days before the screening visit and patients for whom adjustment of vitamin D sterols is planned from screening until end of study. Adjustment of calcium supplements within 14 days before the screening visit and patients for whom adjustment of calcium supplements is planned from screening until end of study. Adjustment of phosphate binder within 14 days before the screening visit and patients or whom adjustment of phosphate binder is planned from screening until end of study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part 1 SAD<br>four diffferent doses | Drug: LEO 27847<br>* First in patient<br>|
| Placebo Comparator: Part 2a MAD<br>three doses | Drug: LEO 27847<br>* First in patient<br>|
| Active Comparator: Part 2b<br>0.24 mg LEO 27847 | Drug: LEO 27847<br>* First in patient<br>|
| Active Comparator: Part 2c<br>0.24 mg LEO 27847 | Drug: LEO 27847<br>* First in patient<br>|
| Placebo Comparator: Parat 2a MAD<br>one dose | Drug: LEO 27847<br>* First in patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Adverse events, vital signs, ECG, laboratory evaluation, physical examination | 7 days after last dosing | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and tolerability of LEO 27847