Status:
COMPLETED
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
Lead Sponsor:
LEO Pharma
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01167309
Start Date
June 1 2010
End Date
December 1 2011
Last Update
February 24 2025
Active Locations (2)
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1
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
2
Centralny Szpital Kliniczny MON
Warsaw, Poland, 04-141