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

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167309
• Other study ID #: LEO 27847-S02
• Status: Completed
• Phase: Phase 1
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• LEO 27847
First in patient

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel
Poland	Centralny Szpital Kliniczny MON	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Adverse events, vital signs, ECG, laboratory evaluation, physical examination	7 days after last dosing
Secondary	Pharmacokinetics and Pharmacodynamics	LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine	7 days after last dosing