Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)

Amgen

Status and phase

Completed

Phase 2

Conditions

Primary Hyperparathyroidism

Treatments

Drug: Cinacalcet

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03776058

00990160

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

Any unstable medical condition requiring hospitalization within 30 days before day 0, or otherwise unstable condition in the judgment of the investigator
Awaiting or scheduled for parathyroidectomy within 2 months after study day 0
Pregnant or nursing
Received, within 21 days before day 0, therapy with systemic glucocorticoids (> 5 mg/day prednisone or equivalent), lithium, tricyclic antidepressants (with the exception of amitriptyline and nortriptyline), thioridazine, haloperidol, flecainide, drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (ie, thiazide or loop diuretics), or calcitonin
Dose changes in bisphosphonates, thyroid replacement therapy, selective estrogen receptor modulators (SERMs), or changes in daily doses of estrogen (greater than 0.75 mg) within 90 days before day 0
Subjects who discontinued estrogen or SERM therapy must have been off treatment for at least 90 days before day 0.
Alcohol or illicit drug abuse within 12 months before day 0 based on self-report
Myocardial infarction within 6 months before day 0
Ventricular rhythm disturbance requiring current treatment
Seizure within 12 months before day 0
History (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer
Evidence (within 5 years) of treatment for and/or active sarcoidosis, tuberculosis, or diseases other than primary HPT known to cause hypercalcemia
History of familial hypocalciuric hypercalcemia (FHH)
Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0
Gastrointestinal disorder that may be associated with impaired absorption of orally administered medications
Inability to swallow tablets similar in size to an aspirin tablet
Known sensitivity to products administered during the study
Previous participation as a subject in this study (ie, withdrawn early) or a prior study involving AMG 073 administration
Enrolled in, or not yet completed at least 28 days since ending other investigational device or drug trial(s)
Psychiatric disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements
Any other condition that might reduce the chance of obtaining data (ie, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent