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

Phase 1

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: LEO 27847

• Registration Number: NCT01167309
• Lead Sponsor: LEO Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-22
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2013-10
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1 SAD	LEO 27847	four diffferent doses
Part 2a MAD	LEO 27847	three doses
Part 2b	LEO 27847	0.24 mg LEO 27847
Part 2c	LEO 27847	0.24 mg LEO 27847
Parat 2a MAD	LEO 27847	one dose

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	7 days after last dosing	Adverse events, vital signs, ECG, laboratory evaluation, physical examination

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and Pharmacodynamics	7 days after last dosing	LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine

Trial Locations

Locations (2)

CRS Clinical Research Services Kiel GmbH; 🇩🇪 Kiel, Germany

Centralny Szpital Kliniczny MON; 🇵🇱 Warszawa, Poland