A single-dose study to assess the safety and the manner in which the body metabolizes (breaks down) and gets rid of cinacalcet HCl, specifically in children with kidney failure who are being treated with dialysis.

An Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to < 6 Years with Chronic Kidney Disease Receiving Dialysis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017999-25-GB

Enrollment

Registered

2010-06-21

Start date

2010-11-12

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyroidism (HPT) in subjects with chronic kidney disease (CKD) receiving maintenance hemodialysis. MedDRA version: 14.1 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Name: Cinacalcet Product Code: AMG 073 Pharmaceutical Form: Capsule INN or Proposed INN: Cinacalcet CAS Number: 364782-34-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: General Subject’s parent, or legally acceptable guardian, must sign an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form (ICF). At the discretion of the investigator, subject assent may also be obtained. Disease Related Subjects 28 days to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Disease Related Current or historic malignancy Cardiac ventricular arrhythmias within 28 days prior to screening A gastrointestinal disorder or surgery that could affect the absorption of drugs (eg, pyloric stenosis or any gut-shortening surgical procedure prior to screening) History of seizure History of prolongation of the QT interval Corrected QT Interval (QTc) > 500 ms during screening, using Bazett’s Formula QTc = 450 and = 500 ms during screening, using Bazett’s formula Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screening Laboratory Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase (AST) = 1.5 x upper limit of normal (ULN) OR alanine aminotransferase (ALT) = 1.5 x ULN OR total bilirubin = 1 x ULN per institutional laboratory range) at screening or Day-1 Medications Known hypersensitivity to cinacalcet HCl or any of the excipients in cinacalcet HCl Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketokonazole, itraconazole) within the 14 days prior to enrollment and during the study Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (eg, flecainide, vinblastine, thioridazine, tricyclic antidepressants such as desipramine and imipramine, and beta-blockers such as metoprolol or carvedilol) General Subjects who have participated in a clinical trial of an investigational drug/or device within 90 days prior to enrollment

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the safety and tolerability of cinacalcet HCl after single administration to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis ;Primary end point(s): Treatment-emergent adverse events, including clinically significant changes in physical examinations, laboratory safety tests, electrocardiograms (ECG), and vital signs; Secondary Objective: • To evaluate the PK of cinacalcet HCl after single administration to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis • To evaluate pharmacodynamic (PD) parameters of plasma intact parathyroid hormone (iPTH), serum calcium (total calcium, albumin corrected calcium and ionized calcium) following single administration of cinacalcet HCl to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis. • To evaluate correlations of PK parameters and age, weight and body surface area • To evaluate correlations of PK parameters and PD parameters ; Timepoint(s) of evaluation of this end point: AEs: Screening, day -1, pre-dose, at 0, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose, days 2, 3, 4 and 7. Physical examinations: Screening, day -1 and day 4 Laboratory tests: Screening, Day -1, at 2 hours post dose and Day 3. In addition, subjects will be randomly assigned to an 8 hour or 12 hour post dose collection ECGs: Screening, day -1 and day 4 Vital signs: Screening, day -1, pre-dose, days 2, 3 and 4.	—

Measure

Time frame

Main Objective: • To evaluate the safety and tolerability of cinacalcet HCl after single administration to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis ;Primary end point(s): Treatment-emergent adverse events, including clinically significant changes in physical examinations, laboratory safety tests, electrocardiograms (ECG), and vital signs; Secondary Objective: • To evaluate the PK of cinacalcet HCl after single administration to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis • To evaluate pharmacodynamic (PD) parameters of plasma intact parathyroid hormone (iPTH), serum calcium (total calcium, albumin corrected calcium and ionized calcium) following single administration of cinacalcet HCl to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis. • To evaluate correlations of PK parameters and age, weight and body surface area • To evaluate correlations of PK parameters and PD parameters ; Timepoint(s) of evaluation of this end point: AEs: Screening, day -1, pre-dose, at 0, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose, days 2, 3, 4 and 7. Physical examinations: Screening, day -1 and day 4 Laboratory tests: Screening, Day -1, at 2 hours post dose and Day 3. In addition, subjects will be randomly assigned to an 8 hour or 12 hour post dose collection ECGs: Screening, day -1 and day 4 Vital signs: Screening, day -1, pre-dose, days 2, 3 and 4.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: PK at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose, days 2, 3 and 4. PD at Screening, day -1, 2 hours post-dose and Day 3. In addition, subjects will be randomly assigned to an 8- or 12-hour post dose collection ; Secondary end point(s): Rich sampling PK parameters of cinacalcet (AUC, Cmax, tmax and t½) PD parameters of iPTH, and measurements of serum calcium (total calcium, albumin corrected calcium and ionized calcium)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: PK at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose, days 2, 3 and 4. PD at Screening, day -1, 2 hours post-dose and Day 3. In addition, subjects will be randomly assigned to an 8- or 12-hour post dose collection ; Secondary end point(s): Rich sampling PK parameters of cinacalcet (AUC, Cmax, tmax and t½) PD parameters of iPTH, and measurements of serum calcium (total calcium, albumin corrected calcium and ionized calcium)

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Countries

Belgium, Germany, United Kingdom, United States

Contacts

Public ContactIHQ Medical Info - Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026