Back to resultsLEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LEO 27847
Sponsored by
About this trial
This is an interventional other trial for Secondary Hyperparathyroidism focused on measuring Safety and tolerability of LEO 27847
Eligibility 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.
Sites / Locations
- CRS Clinical Research Services Kiel GmbH
- Centralny Szpital Kliniczny MON
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Part 1 SAD
Part 2a MAD
Part 2b
Part 2c
Parat 2a MAD
Arm Description
four diffferent doses
three doses
0.24 mg LEO 27847
0.24 mg LEO 27847
one dose
Outcomes
Primary Outcome Measures
Safety and Tolerability
Adverse events, vital signs, ECG, laboratory evaluation, physical examination
Secondary Outcome Measures
Pharmacokinetics and Pharmacodynamics
LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01167309
Brief Title
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
Official Title
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Safety and tolerability of LEO 27847
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 SAD
Arm Type
Active Comparator
Arm Description
four diffferent doses
Arm Title
Part 2a MAD
Arm Type
Placebo Comparator
Arm Description
three doses
Arm Title
Part 2b
Arm Type
Active Comparator
Arm Description
0.24 mg LEO 27847
Arm Title
Part 2c
Arm Type
Active Comparator
Arm Description
0.24 mg LEO 27847
Arm Title
Parat 2a MAD
Arm Type
Placebo Comparator
Arm Description
one dose
Intervention Type
Drug
Intervention Name(s)
LEO 27847
Intervention Description
First in patient
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Adverse events, vital signs, ECG, laboratory evaluation, physical examination
Time Frame
7 days after last dosing
Secondary Outcome Measure Information:
Title
Pharmacokinetics and Pharmacodynamics
Description
LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine
Time Frame
7 days after last dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef Halabi, MD
Organizational Affiliation
CRS Clinical Research Services Kiel GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRS Clinical Research Services Kiel GmbH
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Centralny Szpital Kliniczny MON
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
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