EUCTR2009-017999-25-DE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- •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)
- •Subjects who have participated in a clinical trial of an investigational drug/or device within 90 days prior to enrollment
研究者
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