Study of the bioavailability of cinacalcet capsules compared to the approved cinacalcet tablets

• Conditions: Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma; MedDRA version: 17.1Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-005034-66-Outside-EU/EEA
• Lead Sponsor: Amgen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-13
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

- Healthy men and women 18 to 45 years of age, inclusive at the time of randomization.
- Clinically acceptable physical examination (including blood pressure and heart rate measurements), laboratory tests (blood hematology, blood chemistries and urinalysis), ECG (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals) and no history of evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.
- A body mass index between 18-32 kg/m2, inclusive at the time of screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Clinically significant abnormality in clinical chemistry, hematology or urinalysis parameters, as determined by the investigator and Amgen.
- History of epilepsy or seizure disorder.
- History of cardiac arrhythmia.
- Serum calcium < 9.0 mg/dL at screening or Day-1.
- Known allergies to cinacalcet or its excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified