E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis
and for the treatment of hypercalcemia in patients with parathyroid carcinoma
|
|
E.1.1.1 | Medical condition in easily understood language |
Secondary hyperparathyroidism in patients and chronic kidney disease |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020708 |
E.1.2 | Term | Hyperparathyroidism secondary |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the bioequivalence of the
5-mg capsule and 30-mg tablet formulations based on AUC0-inf, AUC0-t, and Cmax, administered
orally as capsule contents sprinkled over applesauce, or administered orally as one whole tablet
with applesauce in healthy adult volunteers. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability (eg, subject incidence of
treatment-emergent adverse events, clinically significant changes in laboratory tests, ECGs and
vital signs) and additional PK parameters (eg, tmax and t1/2) of cinacalcet in healthy adult
volunteers. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy men and women ≥ 18 to ≤ 65 years old at the time of randomization with
no history or evidence of clinically relevant medical disorders as determined by
the investigator and the Amgen physician.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening.
- Physical examination including vital signs, clinical laboratory values, and ECGs
are clinically acceptable to the investigator. Abnormal findings will be discussed
with Amgen prior to study enrolment. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
AUC0-inf, AUC0-t and Cmax of each treatment type (six 5 mg capsule contents
sprinkled over applesauce, and the single 30 mg commercial formulation tablet with applesauce)
in healthy adult volunteers. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Safety and tolerability as measured by the subject incidence of
treatment-emergent adverse events, clinically significant changes in laboratory tests, ECGs and
vital signs; and additional PK parameters (eg, tmax and t1/2). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
This study uses a crossover design where subjects serve as their own control |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Subject participation is complete once end-of-study procedures are performed per the SOA
For a full list of study procedures, including the timing of each procedure. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 14 |