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

NCT03776058 | Completed Phase 2 FDA Drug

• 1 other identifier: 00990160
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  4 weeks

• Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments

  4 weeks

Secondary Outcomes (10)

• Percent Change from Baseline in Serum Calcium

  Baseline and week 4

• Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)

  Baseline and week 4

• 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

Study Arms (2)

Cinacalcet

EXPERIMENTAL

Participants received 65 mg cinacalcet orally twice a day for 4 weeks.

Drug: Cinacalcet

Placebo

PLACEBO COMPARATOR

Participants received placebo to cinacalcet orally twice a day for 4 weeks.

Drug: Placebo

Interventions

Cinacalcet DRUG

Tablets for oral administration

Also known as: AMG 073, Sensipar®, Mimpara®

Cinacalcet

Placebo DRUG

Tablets for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Amgen: lead

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: June 15, 2000
• Primary Completion: December 26, 2000
• Study Completion: December 26, 2000
• Last Updated: December 14, 2018

Record last verified: 2018-12