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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01167309
First received: July 2, 2010
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
 Drug: LEO 27847
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 7 days after last dosing ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, ECG, laboratory evaluation, physical examination


Secondary Outcome Measures:
  • Pharmacokinetics and Pharmacodynamics [ Time Frame: 7 days after last dosing ] [ Designated as safety issue: No ]
    LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine


Enrollment: 72
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: LEO 27847
    First in patient
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167309

Locations
Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
Poland
Centralny Szpital Kliniczny MON
Warszawa, Poland, 04-141
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Atef Halabi, MD CRS Clinical Research Services Kiel GmbH
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01167309     History of Changes
Other Study ID Numbers: LEO 27847-S02
Study First Received: July 2, 2010
Last Updated: January 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by LEO Pharma:
Safety and tolerability of LEO 27847

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Parathyroid Diseases
 Endocrine System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013