Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma MedDRA version: 17.1 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Amgen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy men and women 18 to 45 years of age, inclusive at the time of randomization. - Clinically acceptable physical examination (including blood pressure and heart rate measurements), laboratory tests (blood hematology, blood chemistries and urinalysis), ECG (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals) and no history of evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures. - A body mass index between 18-32 kg/m2, inclusive at the time of screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. - Clinically significant abnormality in clinical chemistry, hematology or urinalysis parameters, as determined by the investigator and Amgen. - History of epilepsy or seizure disorder. - History of cardiac arrhythmia. - Serum calcium < 9.0 mg/dL at screening or Day-1. - Known allergies to cinacalcet or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the comparative bioavailability based on AUC0-inf, AUC0-t, and Cmax, between six of the 5 mg capsules of cinacalcet swallowed whole with applesauce, contents of six of the 5 mg capsules sprinkled over applesauce, and a single 30 mg commercial formulation tablet of cinacalcet with applesauce in healthy adult volunteers under fasted conditions.;Secondary Objective: To assess the safety and tolerability (eg, subject incidence of treatment-emergent adverse events, clinically significant changes in laboratory tests, ECGs and vital signs) and additional PK parameters (tmax and t1/2) of cinacalcet in healthy adult volunteers under fasted conditions. ;Primary end point(s): AUC0-inf, AUC0-t, and Cmax of each treatment type (six 5 mg capsules swallowed whole with applesauce, six 5 mg capsules sprinkled over applesauce, and the single 30 mg commercial formulation tablet with applesauce) in healthy adult volunteers under fasted conditions.;Timepoint(s) of evaluation of this end point: At end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability as measured by the subject incidence of treatment-emergent adverse events, clinically significant changes in laboratory tests, ECGs and vital signs; and additional PK parameters (tmax and t1/2) under fasted conditions.;Timepoint(s) of evaluation of this end point: At end of study | — |
Countries
United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed