| Outcome Measures: |
Primary: Number of Participants With Adverse Events, A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension., Day 1 to day 30 | Secondary: Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet, Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet, Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Maximum Observed Plasma Concentration (Cmax) of Cinacalcet, Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax), Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Terminal Half-life of Cinacalcet, The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase., Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Percent Change From Baseline in Intact Parathyroid Hormone, Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.|Percent Change From Baseline in Total Calcium, Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|Percent Change From Baseline in Albumin Corrected Calcium, Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|Percent Change From Baseline in Ionized Calcium, Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
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| Locations: |
Research Site, Los Angeles, California, 90095, United States|Research Site, San Francisco, California, 94143, United States|Research Site, Louisville, Kentucky, 40202, United States|Research Site, Kansas City, Missouri, 64108, United States|Research Site, Heidelberg, 69120, Germany|Research Site, Bristol, BS2 8BJ, United Kingdom|Research Site, Glasgow, G3 8SJ, United Kingdom|Research Site, Leeds, LS1 3EX, United Kingdom|Research Site, Manchester, M13 9WL, United Kingdom|Research Site, Nottingham, NG7 2UH, United Kingdom
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