Primary Hyperparathyroidism
Conditions
Brief summary
The primary objectives were to assess the safety and tolerability of twice daily (BID) doses of 65 mg cinacalcet administered orally to adults with primary HPT.
Interventions
DRUGCinacalcet
Tablets for oral administration
DRUGPlacebo
Tablets for oral administration
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women ≥ 18 years old before beginning of screening * Use, in the opinion of the principal investigator, effective contraceptive measures throughout the study * Negative serum pregnancy test within 15 days before day 0 * Plasma iPTH concentration \> 45 pg/mL on at least 2 occasions (during the screening phase) at least 7 days apart * Serum calcium concentration ≥ 11 mg/dL on 2 occasions (during the screening phase) at least 7 days apart * Acceptable renal function, with an estimated creatinine clearance \> 50 mL/min as determined by the Cockroft and Gault equation * Acceptable hepatic function, defined as serum aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin ≤ 2 times the upper limit of normal (central laboratory's range) * Laboratory test results within the central laboratory's normal range for hematology, coagulation, urinalysis, and clinical chemistry parameters not mentioned specifically in other inclusion/
Exclusion criteria
* Chest x-ray within the past 12 months, with no evidence of an active infectious, inflammatory, or malignant process * Informed consent for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 4 weeks |
| Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP) | Baseline and week 4 |
| Percent Change from Baseline in 1,25 dihydroxy Vitamin D3 | Baseline and week 4 |
| Percent Change from Baseline in Serum Phosphorus | Baseline and week 4 |
| Percent Change from Baseline in N-telopeptide (NTx) | Baseline and week 4 |
| Percent Change from Baseline in Serum Calcium | Baseline and week 4 |
| Percent Change from Baseline in Calcium/Creatinine Ratio | Baseline and week 4 |
| Percent Change from Baseline in Phosphorus/Creatinine Ratio | Baseline and week 4 |
| Percent Change from Baseline in N-telopeptide/Creatinine Ratio | Baseline and week 4 |
| Percent Change from Baseline in Urine Osmolality | Baseline and week 4 |
| Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH) | Baseline and week 4 |
Outcome results
None listed