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.
- Conditions
- Secondary hyperparathyroidism (HPT) in subjects with chronic kidney disease (CKD) receiving maintenance hemodialysis.MedDRA version: 18.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2009-017999-25-BE
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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 < 6 years of age with CKD and secondary hyperparathyroidism (sHPT) as diagnosed by principal investiators, undergoing hemodialysis or
peritoneal dialysis at the time of screening (subjects 6 months or older should have been receiving dialysis for = 2 months) and who have not received any cinacalcet HCl therapy for at least 2 weeks prior to dosing on Day 1
Free of any disease or condition (other than those diseases or conditions related to their renal disease, that, in the opinion of the investigator, would impact the subject’s safety or the integrity of the study data)
Demographic
Must weigh = 6 kg at screening and at Day-1
Must be at least 30 weeks of gestational age
Physical examination must be acceptable to the investigator at screening and at Day-1
Laboratory
Hemoglobin = 8 g/dL at screening and at Day-1
Serum calcium within normal ranges at screening and at Day-1
Normal or clinically acceptable ECG (12-lead reporting RR, PR, QRS, and QT intervals) at screening and at Day-1
Clinical laboratory tests that are acceptable to the investigator at screening and at Day -1
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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)
A new onset of seizure or worsening of a pre-existing seizure disorder
within 2 months prior to IP administration
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method