<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774771</url>
  </required_header>
  <id_info>
    <org_study_id>00980125</org_study_id>
    <nct_id>NCT03774771</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-week Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Clinical Effects of an Oral Calcimimetic Agent (AMG 073) in Primary Hyperparathyroidism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective was to assess the safety and tolerability of cinacalcet in adults with&#xD;
      primary hyperparathyroidism (HPT) when administered as a single oral once daily doses for 6&#xD;
      consecutive weeks and twice daily for 15 consecutive days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 1998</start_date>
  <completion_date type="Actual">December 13, 1999</completion_date>
  <primary_completion_date type="Actual">December 13, 1999</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events in Part 1 and Part 2</measure>
    <time_frame>6 weeks in Part 1 and 15 days in Part 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Serum Calcium Concentration</measure>
    <time_frame>Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Calcium Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Calcium Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Calcium Concentration in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Calcium Concentration in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time When Serum Calcium was Below Baseline During the 24-hour Dosing Interval in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time When Serum Calcium was Below Baseline During the 12-hour Dosing Interval in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Plasma Intact parathyroid Hormone (iPTH) Concentration</measure>
    <time_frame>Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma iPTH Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma iPTH Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum iPTH Concentration in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum iPTH Concentration in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Minimum iPTH Concentration in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Minimum iPTH Concentration in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time When iPTH was Below Baseline During the 24-hour Dosing Interval in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time When iPTH was Below Baseline During the 12-hour Dosing Interval in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time iPTH was Below 45 pg/mL in Part 1</measure>
    <time_frame>Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Time iPTH was Below 45 pg/mL in Part 2</measure>
    <time_frame>Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Serum Calcitonin Concentration</measure>
    <time_frame>Baseline and days 8, 15, and 43 in Part 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Serum Calcitonin Concentration Less than 10 pg/mL</measure>
    <time_frame>Baseline and days 8, 15 and 43 in Part 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP) Concentration</measure>
    <time_frame>Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with BALP Concentration Within Normal Range</measure>
    <time_frame>Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2</time_frame>
    <description>Normal range of BALP is 2.9 to 20.1 ng/mL for men 20 to 79 years of age and and 3.7 to 20.9 ng/mL for women 20 to 79 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Serum N-telopeptide (NTx) Concentration</measure>
    <time_frame>Baseline and days 8 and 15 in Part 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Serum NTx Concentration Within Normal Range</measure>
    <time_frame>Baseline and days 8 and 15 in Part 1</time_frame>
    <description>Normal range of serum NTx is 5.4 to 24.2 nmoL bone collagen equivalents (BCE)/L for men, 6.2 to 19.0 nmoL BCE/L for premenopausal women, and 5.3 to 35.8 nmol BCE/L for postmenopausal women (≥ 55 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Urinary NTx Concentration</measure>
    <time_frame>Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Urinary NTx Concentration Within Normal Range</measure>
    <time_frame>Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2</time_frame>
    <description>Normal range of urinary NTx is is 0.0 to 85.0 nmoL BCE/mmoL creatinine for men, 5.0 to 65.0 nmoL BCE/mmoL creatinine for premenopausal women, and 0.0 to 130.0 nmoL BCE/mmoL creatinine for postmenopausal women [≥ 55 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Urinary Calcium/Creatinine Ratio</measure>
    <time_frame>Baseline and days 8 and 15 in Part 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Urinary Calcium Concentration</measure>
    <time_frame>Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Urinary Calcium Concentration Within Normal Range</measure>
    <time_frame>Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2</time_frame>
    <description>Normal range of urinary calcium is 50 to 300 mg/24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in 1,25-Dihydroxy Vitamin D</measure>
    <time_frame>Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with 1,25-Dihydroxy Vitamin D Concentration in the Normal Range</measure>
    <time_frame>Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2</time_frame>
    <description>The normal range for 1,25-dihydroxy vitamin D3 is 16.0 to 65.0 pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Urinary and Serum Phosphorus Concentrations</measure>
    <time_frame>Baseline and days 8, 15, and 22 in Part 2</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Primary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In Part 1 participants received placebo capsules orally once a day for 6 weeks. In Part 2 participants received placebo capsules twice a day for 15 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cinacalcet 50 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1 participants received 50 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 30 mg cinacalcet capsules twice a day for 15 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cinacalcet 75 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1 participants received 75 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 40 mg cinacalcet capsules twice a day for 15 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cinacelcet 100 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1 participants received 100 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 50 mg cinacalcet capsules twice a day for 15 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cinacalcet</intervention_name>
    <description>Capsule for oral administration</description>
    <arm_group_label>Cinacalcet 50 mg QD</arm_group_label>
    <arm_group_label>Cinacalcet 75 mg QD</arm_group_label>
    <arm_group_label>Cinacelcet 100 mg QD</arm_group_label>
    <other_name>AMG 073</other_name>
    <other_name>Sensipar®</other_name>
    <other_name>Mimpara®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules for oral administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females ≥ 18 years of age at screening. In Part 1, females must be&#xD;
             postmenopausal (at least 12 months since last menstrual period) or surgically sterile.&#xD;
&#xD;
             In Part 2, all qualified females replacing a Part 1 subject (i.e., naïve subjects),&#xD;
             regardless of reproductive status, may participate if, in the opinion of the principal&#xD;
             investigator, an appropriate effective contraceptive method is used throughout the&#xD;
             study. All females must have a negative serum pregnancy test within 28 days prior to&#xD;
             Baseline (Parts 1 and 2).&#xD;
&#xD;
          2. Men and women participating in this study must agree to use, in the opinion of the&#xD;
             principal investigator, highly effective contraceptive measures throughout the study.&#xD;
             All females who are pregnant or breast-feeding are excluded. All subjects must notify&#xD;
             the principal investigator if they or their partner suspects a pregnancy.&#xD;
&#xD;
          3. Diagnosis of primary HPT. A plasma intact PTH concentration ≥ 45 pg/mL on at least two&#xD;
             occasions at least 1 week apart during the 12 months prior to baseline (at least one&#xD;
             of these determinations should be made during screening), and a corrected total serum&#xD;
             calcium concentration (for each 1 g/dL decrease in albumin level below 4.0 g/dL, the&#xD;
             calcium value should be increased by 0.8 mg/dL) greater than the upper limit of&#xD;
             normal, but no greater than 12.5 mg/dL.&#xD;
&#xD;
          4. Acceptable renal function, with an estimated creatinine clearance &gt; 50 ml/min as&#xD;
             determined by the Cockroft and Gault equation.&#xD;
&#xD;
          5. Acceptable hepatic function, defined as serum aspartate aminotransferase (AST),&#xD;
             alanine aminotransferase (ALT), and total bilirubin &lt; 2 times the upper limit of&#xD;
             normal.&#xD;
&#xD;
          6. Fasting (8 hours) serum glucose ≤ 130 mg/dL and hemoglobin Alc within the central&#xD;
             laboratory's normal range.&#xD;
&#xD;
          7. Hematology panel, serum clinical chemistry and urinalysis results within normal ranges&#xD;
&#xD;
          8. Chest x-ray without evidence of active, infectious, inflammatory or malignant process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any unstable medical condition, defined as having been hospitalized within 28 at prior&#xD;
             to baseline, or otherwise unstable in the judgement of the investigator.&#xD;
&#xD;
          2. Received within 21 day prior to baseline, therapy with systemic glucocorticoids,&#xD;
             lithium, tricyclic antidepressants, thioridazine, haloperidol, flecainide, or other&#xD;
             drugs with a narrow therapeutic index that are primarily metabolized by hepatic&#xD;
             cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (e.g.&#xD;
             thiazide or loop diuretics), and drugs that affect bone metabolism (e.g. calcitonin,&#xD;
             selective estrogen receptor modulators [SERMs])&#xD;
&#xD;
          3. Received, within 90 days prior to Baseline, chronic therapy with bisphosphonates or&#xD;
             fluoride.&#xD;
&#xD;
          4. Known alcohol abuse, or use of illicit drugs, within 12 months prior to Baseline&#xD;
&#xD;
          5. Experienced a myocardial infarction (MI) within 6 months prior to Baseline&#xD;
&#xD;
          6. A ventricular rhythm disturbance requiring current treatment&#xD;
&#xD;
          7. Received investigational drugs within 28 days prior to Baseline&#xD;
&#xD;
          8. A history of seizures within 12 months prior to Baseline&#xD;
&#xD;
          9. A history (within 5 years) of malignancy of any type, other than nonmelanomatous skin&#xD;
             cancers or in situ cervical cancer&#xD;
&#xD;
         10. A gastrointestinal disorder that may be associated with impaired absorption of orally&#xD;
             administered medications&#xD;
&#xD;
         11. A Body Mass Index (BMI) &lt; 15 or &gt; 40, obtained during screening&#xD;
&#xD;
         12. An inability to swallow capsules&#xD;
&#xD;
         13. Sarcoidosis, tuberculosis, or other diseases known to cause hypercalcemia&#xD;
&#xD;
         14. Fasting spot urine calcium/creatinine ratio (mg) &lt; 0.05&#xD;
&#xD;
         15. A psychiatric disorder that would interfere with understanding and giving informed&#xD;
             consent or compliance with protocol requirements&#xD;
&#xD;
         16. Any other condition that might reduce the chance of obtaining data (eg, known poor&#xD;
             compliance) required by the protocol or that might compromise the ability to give&#xD;
             truly informed consent.&#xD;
&#xD;
         17. For Part 2, a subject from Part 1 who discontinued treatment early&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Primary</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cinacalcet</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774771
org study id: 00980125
nct id: NCT03774771
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective was to assess the safety and tolerability of cinacalcet in adults with
      primary hyperparathyroidism (HPT) when administered as a single oral once daily doses for 6
      consecutive weeks and twice daily for 15 consecutive days.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants with Adverse Events in Part 1 and Part 2
time frame: 6 weeks in Part 1 and 15 days in Part 2
measure: Percent Change from Baseline in Serum Calcium Concentration
time frame: Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.
measure: Area Under the Serum Calcium Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
measure: Area Under the Serum Calcium Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Minimum Serum Calcium Concentration in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
measure: Minimum Serum Calcium Concentration in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Cumulative Time When Serum Calcium was Below Baseline During the 24-hour Dosing Interval in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
measure: Cumulative Time When Serum Calcium was Below Baseline During the 12-hour Dosing Interval in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
measure: Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Percent Change from Baseline in Plasma Intact parathyroid Hormone (iPTH) Concentration
time frame: Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.
measure: Area Under the Plasma iPTH Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
measure: Area Under the Plasma iPTH Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Minimum iPTH Concentration in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
measure: Minimum iPTH Concentration in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Time of Minimum iPTH Concentration in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
measure: Time of Minimum iPTH Concentration in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Cumulative Time When iPTH was Below Baseline During the 24-hour Dosing Interval in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
measure: Cumulative Time When iPTH was Below Baseline During the 12-hour Dosing Interval in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Cumulative Time iPTH was Below 45 pg/mL in Part 1
time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
measure: Cumulative Time iPTH was Below 45 pg/mL in Part 2
time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
measure: Percent Change from Baseline in Serum Calcitonin Concentration
time frame: Baseline and days 8, 15, and 43 in Part 1
measure: Percentage of Participants with Serum Calcitonin Concentration Less than 10 pg/mL
time frame: Baseline and days 8, 15 and 43 in Part 1
measure: Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP) Concentration
time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
measure: Percentage of Participants with BALP Concentration Within Normal Range
time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
description: Normal range of BALP is 2.9 to 20.1 ng/mL for men 20 to 79 years of age and and 3.7 to 20.9 ng/mL for women 20 to 79 years of age.
measure: Percent Change from Baseline in Serum N-telopeptide (NTx) Concentration
time frame: Baseline and days 8 and 15 in Part 1
measure: Percentage of Participants with Serum NTx Concentration Within Normal Range
time frame: Baseline and days 8 and 15 in Part 1
description: Normal range of serum NTx is 5.4 to 24.2 nmoL bone collagen equivalents (BCE)/L for men, 6.2 to 19.0 nmoL BCE/L for premenopausal women, and 5.3 to 35.8 nmol BCE/L for postmenopausal women (≥ 55 years).
measure: Percent Change from Baseline in Urinary NTx Concentration
time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
measure: Percentage of Participants with Urinary NTx Concentration Within Normal Range
time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
description: Normal range of urinary NTx is is 0.0 to 85.0 nmoL BCE/mmoL creatinine for men, 5.0 to 65.0 nmoL BCE/mmoL creatinine for premenopausal women, and 0.0 to 130.0 nmoL BCE/mmoL creatinine for postmenopausal women [≥ 55 years).
measure: Percent Change from Baseline in Urinary Calcium/Creatinine Ratio
time frame: Baseline and days 8 and 15 in Part 1
measure: Percent Change from Baseline in Urinary Calcium Concentration
time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
measure: Percentage of Participants with Urinary Calcium Concentration Within Normal Range
time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
description: Normal range of urinary calcium is 50 to 300 mg/24 hours.
measure: Percent Change from Baseline in 1,25-Dihydroxy Vitamin D
time frame: Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2
measure: Percentage of Participants with 1,25-Dihydroxy Vitamin D Concentration in the Normal Range
time frame: Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2
description: The normal range for 1,25-dihydroxy vitamin D3 is 16.0 to 65.0 pg/mL.
measure: Percent Change from Baseline in Urinary and Serum Phosphorus Concentrations
time frame: Baseline and days 8, 15, and 22 in Part 2
arm group label: Placebo
arm group type: Placebo Comparator
description: In Part 1 participants received placebo capsules orally once a day for 6 weeks. In Part 2 participants received placebo capsules twice a day for 15 days.
arm group label: Cinacalcet 50 mg QD
arm group type: Experimental
description: In Part 1 participants received 50 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 30 mg cinacalcet capsules twice a day for 15 days.
arm group label: Cinacalcet 75 mg QD
arm group type: Experimental
description: In Part 1 participants received 75 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 40 mg cinacalcet capsules twice a day for 15 days.
arm group label: Cinacelcet 100 mg QD
arm group type: Experimental
description: In Part 1 participants received 100 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 50 mg cinacalcet capsules twice a day for 15 days.
intervention type: Drug
intervention name: Cinacalcet
description: Capsule for oral administration
arm group label: Cinacalcet 50 mg QD
arm group label: Cinacalcet 75 mg QD
arm group label: Cinacelcet 100 mg QD
other name: AMG 073
other name: Sensipar®
other name: Mimpara®
intervention type: Drug
intervention name: Placebo
description: Capsules for oral administration
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Primary
mesh term: Cinacalcet