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.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism
• Intervention / Treatment: Drug: LEO 27847

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • CRS Clinical Research Services Kiel GmbH
• Poland
  • Warszawa, Poland, 04-141
    • Centralny Szpital Kliniczny MON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Safety and tolerability of LEO 27847
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary
• Other Study ID Numbers: LEO 27847-S02