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

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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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Kiel GmbH, Kiel, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEO 27847

Drug

First in patient

Primary outcomes

Safety and Tolerability

Time frame: 7 days after last dosing

Adverse events, vital signs, ECG, laboratory evaluation, physical examination

Secondary outcomes

Pharmacokinetics and Pharmacodynamics

Time frame: 7 days after last dosing

LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jul 22, 2010
Registry last updated: Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed