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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167309
First Posted: July 22, 2010
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LEO Pharma
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease

Further study details as provided by LEO Pharma:

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


Secondary Outcome Measures:
  • Pharmacokinetics and Pharmacodynamics [ Time Frame: 7 days after last dosing ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01167309     History of Changes
Other Study ID Numbers: LEO 27847-S02
First Submitted: July 2, 2010
First Posted: July 22, 2010
Last Update Posted: January 23, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases