Secondary Hyperparathyroidism
Conditions
Keywords
Safety and tolerability of LEO 27847
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.
Interventions
DRUGLEO 27847
First in patient
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 7 days after last dosing | Adverse events, vital signs, ECG, laboratory evaluation, physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics and Pharmacodynamics | 7 days after last dosing | LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine |
Countries
Germany, Poland
Outcome results
None listed