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

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

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.

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.