Cinacalcet HCl in Paediatric Subjects with Chronic Kidney Disease

• Research type

  Research Study

• Full title

  An open-label, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Cinacalcet HCl in pediatric subjects aged 28 Days to less than 6 years with chronic kidney disease receiving dialysis

• IRAS ID

  54679

• Contact name

  N Webb

• Eudract number

  2009-017999-25

• Research summary

  Inclusion CriteriaGeneral?½ Signed Informed Consent Form (ICF)Disease Related?½ Subjects 28 days to < 6 years of age with CKD 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?½ Free of disease or condition (other than those diseases or conditions related to their renal disease)Demographic?½ = 6 kg?½ Must be at least 30 weeks of gestational age ?½ Physical examination that is acceptableLaboratory?½ Hemoglobin = 8 g/dL at screening and at Day-1?½ Serum calcium = 8.4 mg/dL?½ Normal or clinically acceptable ECG?½ Clinical laboratory tests that are acceptableExclusion CriteriaDisease Related?½ Current or historic malignancy?½ Cardiac ventricular arrhythmias within 28 days prior to screening?½ A gastrointestinal disorder or surgery that could affect the absorption of drugs(eg, pyloric stenosis or any gut-shortening surgical procedure prior to screening)?½ History of seizure disorder?½ Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screeningLaboratory?½ Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubinMedications?½ Known hypersensitivity to cinacalcet HCl or any of the excipients in cinacalcet HCl?½ Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors within the 14 days prior to enrollment and during the study?½ Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic indexGeneral?½ Subjects who have participated in a clinical trial of an investigational drug/or device within 90 days prior to enrollmentProcedures:Subjects will be screened within the period of -21 to -2 days before dosing on Day 1. Procedures will include, medical history, physical examination, vital signs, body height and weight, 12 lead ECG and safety laboratory testing.Subjects will be visit the research unit on Day -1 for safety laboratory testing including study PD endpoint parameters. Vital signs and the subject??s weight will also be recorded. The subject??s food intake will be recorded from 2 hours pre to 2 hours post-dose. Following pre-dose vital signs measurements on Day 1, subjects will receive a single oral 0.25mg/kg dose of Cinacalcet HCl. Those subjects who have nasogastric or gastrostomy tubes to facilitate feeding will be dosed via these devices. Subject will then undergo a 72 hour schedule of PK and PD sampling. Further vital signs measurements will be conducted on Days 2, 3 and 4. End of study assessments will be conducted on Day 4.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/83

• Date of REC Opinion

  12 Nov 2010

• REC opinion

  Further Information Favourable Opinion