Hyperparathyroidism, Secondary
Conditions
Brief summary
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
Interventions
DRUGEtelcalcetide
Administered as a single intravenous (IV) injection
DRUGPlacebo
Administered as a single intravenous (IV) injection
Sponsors
Nucleus Network Ltd
KAI Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male between 18 and 45 years of age who have provided written informed consent * Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests
Exclusion criteria
* History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator * History of any ongoing medical condition requiring treatment with prescription medication * History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions * Clinically significant abnormalities on screening clinical examination or laboratory safety tests * History of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | From the first dose of study drug through 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Plasma Ionized Calcium | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose | — |
| Change From Baseline in Serum Total Calcium | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose | — |
| Change From Baseline in Serum Corrected Calcium | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose | — |
| Change From Baseline in Serum Phosphate | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose | — |
| Percent Change From Baseline in Serum Calcitonin | Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose | — |
| Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | Baseline and 12, 24, and 48 hours post-dose | — |
| Maximum Observed Concentration (Cmax) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method. |
| Percent Change From Baseline in Serum Parathyroid Hormone | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose | — |
| Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
| Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
| Terminal Elimination Rate Constant (λz) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
| Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
| Total Body Clearance (CL) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
| Volume of Distribution at Steady State for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
| Number of Participants With Antibodies to Etelcalcetide | Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28. | Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA). |
| Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. | — |
Countries
Australia
Participant flow
Recruitment details
This study was conducted at one clinical center in Australia.
Pre-assignment details
The study included 4 cohorts: 0.5 mg, 2 mg, 5 mg and 10 mg. Eight participants were enrolled into each cohort and were randomized 6:2 to receive etelcalcetide or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo Participants received a single dose of placebo administered by intravenous injection. | 8 |
| Etelcalcetide 0.5 mg Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. | 6 |
| Etelcalcetide 2 mg Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. | 6 |
| Etelcalcetide 5 mg Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. | 6 |
| Etelcalcetide 10 mg Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. | 6 |
| Total | 32 |
Baseline characteristics
| Characteristic | Pooled Placebo | Etelcalcetide 0.5 mg | Etelcalcetide 2 mg | Etelcalcetide 5 mg | Etelcalcetide 10 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 22.4 years STANDARD_DEVIATION 3.5 | 27.8 years STANDARD_DEVIATION 8.9 | 26.8 years STANDARD_DEVIATION 4.9 | 24.2 years STANDARD_DEVIATION 4.4 | 26.0 years STANDARD_DEVIATION 6.2 | 25.3 years STANDARD_DEVIATION 5.7 |
| Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity Not Hispanic or Latino | 8 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 31 Participants |
| Race Asian | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race White | 6 Participants | 4 Participants | 6 Participants | 3 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 8 | 0 / 6 | 1 / 6 | 2 / 6 | 2 / 6 | 5 / 24 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 24 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: From the first dose of study drug through 7 days.
Population: The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Adverse Events | Treatment-related adverse events | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Any adverse event | 2 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Deaths | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Pooled Placebo | Number of Participants With Adverse Events | Withdrawals due to adverse events | 0 participants |
| Etelcalcetide 0.5 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 0 participants |
| Etelcalcetide 0.5 mg | Number of Participants With Adverse Events | Withdrawals due to adverse events | 0 participants |
| Etelcalcetide 0.5 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 0.5 mg | Number of Participants With Adverse Events | Deaths | 0 participants |
| Etelcalcetide 0.5 mg | Number of Participants With Adverse Events | Any adverse event | 0 participants |
| Etelcalcetide 2 mg | Number of Participants With Adverse Events | Withdrawals due to adverse events | 0 participants |
| Etelcalcetide 2 mg | Number of Participants With Adverse Events | Any adverse event | 1 participants |
| Etelcalcetide 2 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 2 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 1 participants |
| Etelcalcetide 2 mg | Number of Participants With Adverse Events | Deaths | 0 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Deaths | 0 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Any adverse event | 2 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 1 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Withdrawals due to adverse events | 0 participants |
| Etelcalcetide 5 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Withdrawals due to adverse events | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Treatment-related adverse events | 1 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Any adverse event | 2 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Deaths | 0 participants |
| Etelcalcetide 10 mg | Number of Participants With Adverse Events | Serious adverse events | 0 participants |
Secondary
Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | 81.1 hr*μg/L | Standard Deviation 11.7 |
| Etelcalcetide 0.5 mg | Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | 256 hr*μg/L | Standard Deviation 32.5 |
| Etelcalcetide 2 mg | Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | 544 hr*μg/L | Standard Deviation 57.7 |
| Etelcalcetide 5 mg | Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | 1130 hr*μg/L | Standard Deviation 129 |
Secondary
Change From Baseline in Serum Corrected Calcium
Time frame: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose
Population: Modified intent-to-treat population with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 6 Hours | -0.024 mmol/L | Standard Deviation 0.04 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 30 Minutes | -0.018 mmol/L | Standard Deviation 0.036 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 1 Hour | -0.024 mmol/L | Standard Deviation 0.039 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 3 Hours | -0.001 mmol/L | Standard Deviation 0.035 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 10 Minutes | -0.019 mmol/L | Standard Deviation 0.047 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 9 Hours | -0.010 mmol/L | Standard Deviation 0.041 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 12 Hours | -0.032 mmol/L | Standard Deviation 0.033 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 15 Hours | -0.154 mmol/L | Standard Deviation 0.309 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 18 Hours | -0.067 mmol/L | Standard Deviation 0.076 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 21 Hours | -0.035 mmol/L | Standard Deviation 0.04 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 24 Hours | -0.015 mmol/L | Standard Deviation 0.026 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 27 Hours | 0.040 mmol/L | Standard Deviation 0.041 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 30 Hours | 0.008 mmol/L | Standard Deviation 0.035 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 36 Hours | -0.025 mmol/L | Standard Deviation 0.037 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 42 Hours | 0.001 mmol/L | Standard Deviation 0.06 |
| Pooled Placebo | Change From Baseline in Serum Corrected Calcium | 48 Hours | 0.020 mmol/L | Standard Deviation 0.033 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 36 Hours | 0.008 mmol/L | Standard Deviation 0.046 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 21 Hours | 0.012 mmol/L | Standard Deviation 0.09 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 18 Hours | -0.007 mmol/L | Standard Deviation 0.063 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 42 Hours | -0.023 mmol/L | Standard Deviation 0.061 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 15 Hours | -0.052 mmol/L | Standard Deviation 0.072 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 6 Hours | -0.048 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 3 Hours | -0.002 mmol/L | Standard Deviation 0.043 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 30 Minutes | -0.008 mmol/L | Standard Deviation 0.079 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 10 Minutes | -0.008 mmol/L | Standard Deviation 0.081 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 30 Hours | 0.035 mmol/L | Standard Deviation 0.078 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 9 Hours | -0.102 mmol/L | Standard Deviation 0.079 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 1 Hour | -0.033 mmol/L | Standard Deviation 0.073 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 48 Hours | -0.007 mmol/L | Standard Deviation 0.048 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 27 Hours | 0.030 mmol/L | Standard Deviation 0.085 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 24 Hours | -0.030 mmol/L | Standard Deviation 0.048 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Corrected Calcium | 12 Hours | -0.035 mmol/L | Standard Deviation 0.048 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 36 Hours | -0.038 mmol/L | Standard Deviation 0.081 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 3 Hours | -0.017 mmol/L | Standard Deviation 0.048 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 6 Hours | 0.008 mmol/L | Standard Deviation 0.066 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 9 Hours | -0.120 mmol/L | Standard Deviation 0.218 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 12 Hours | -0.067 mmol/L | Standard Deviation 0.019 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 15 Hours | -0.107 mmol/L | Standard Deviation 0.039 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 42 Hours | 0.022 mmol/L | Standard Deviation 0.026 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 18 Hours | -0.100 mmol/L | Standard Deviation 0.024 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 21 Hours | -0.090 mmol/L | Standard Deviation 0.023 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 24 Hours | -0.018 mmol/L | Standard Deviation 0.036 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 27 Hours | 0.038 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 30 Hours | 0.007 mmol/L | Standard Deviation 0.046 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 10 Minutes | -0.022 mmol/L | Standard Deviation 0.063 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 48 Hours | 0.015 mmol/L | Standard Deviation 0.022 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 30 Minutes | -0.018 mmol/L | Standard Deviation 0.062 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Corrected Calcium | 1 Hour | -0.023 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 21 Hours | -0.150 mmol/L | Standard Deviation 0.072 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 48 Hours | -0.048 mmol/L | Standard Deviation 0.034 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 24 Hours | -0.156 mmol/L | Standard Deviation 0.031 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 36 Hours | -0.103 mmol/L | Standard Deviation 0.068 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 27 Hours | -0.027 mmol/L | Standard Deviation 0.05 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 9 Hours | -0.126 mmol/L | Standard Deviation 0.043 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 30 Hours | -0.125 mmol/L | Standard Deviation 0.067 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 3 Hours | -0.025 mmol/L | Standard Deviation 0.066 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 10 Minutes | -0.017 mmol/L | Standard Deviation 0.053 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 1 Hour | -0.017 mmol/L | Standard Deviation 0.058 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 15 Hours | -0.213 mmol/L | Standard Deviation 0.064 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 6 Hours | -0.045 mmol/L | Standard Deviation 0.058 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 18 Hours | -0.187 mmol/L | Standard Deviation 0.058 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 42 Hours | -0.056 mmol/L | Standard Deviation 0.021 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 12 Hours | -0.173 mmol/L | Standard Deviation 0.026 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Corrected Calcium | 30 Minutes | -0.023 mmol/L | Standard Deviation 0.041 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 30 Hours | -0.138 mmol/L | Standard Deviation 0.064 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 21 Hours | -0.228 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 42 Hours | -0.067 mmol/L | Standard Deviation 0.036 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 6 Hours | -0.130 mmol/L | Standard Deviation 0.069 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 30 Minutes | -0.042 mmol/L | Standard Deviation 0.037 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 15 Hours | -0.255 mmol/L | Standard Deviation 0.078 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 24 Hours | -0.214 mmol/L | Standard Deviation 0.063 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 48 Hours | -0.087 mmol/L | Standard Deviation 0.03 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 9 Hours | -0.163 mmol/L | Standard Deviation 0.069 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 18 Hours | -0.272 mmol/L | Standard Deviation 0.1 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 10 Minutes | -0.030 mmol/L | Standard Deviation 0.049 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 27 Hours | -0.115 mmol/L | Standard Deviation 0.055 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 12 Hours | -0.228 mmol/L | Standard Deviation 0.042 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 36 Hours | -0.157 mmol/L | Standard Deviation 0.051 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 3 Hours | -0.043 mmol/L | Standard Deviation 0.028 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Corrected Calcium | 1 Hour | -0.042 mmol/L | Standard Deviation 0.026 |
Secondary
Change From Baseline in Serum Phosphate
Time frame: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose
Population: Modified intent-to-treat population with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Change From Baseline in Serum Phosphate | 6 Hours | 0.008 mmol/L | Standard Deviation 0.153 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 30 Minutes | -0.041 mmol/L | Standard Deviation 0.067 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 1 Hour | -0.055 mmol/L | Standard Deviation 0.079 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 3 Hours | 0.000 mmol/L | Standard Deviation 0.093 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 10 Minutes | -0.033 mmol/L | Standard Deviation 0.035 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 9 Hours | 0.130 mmol/L | Standard Deviation 0.174 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 12 Hours | 0.015 mmol/L | Standard Deviation 0.086 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 15 Hours | 0.228 mmol/L | Standard Deviation 0.251 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 18 Hours | 0.381 mmol/L | Standard Deviation 0.15 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 21 Hours | 0.278 mmol/L | Standard Deviation 0.164 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 24 Hours | -0.003 mmol/L | Standard Deviation 0.079 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 27 Hours | -0.085 mmol/L | Standard Deviation 0.156 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 30 Hours | 0.060 mmol/L | Standard Deviation 0.21 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 36 Hours | 0.116 mmol/L | Standard Deviation 0.127 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 42 Hours | 0.335 mmol/L | Standard Deviation 0.155 |
| Pooled Placebo | Change From Baseline in Serum Phosphate | 48 Hours | 0.044 mmol/L | Standard Deviation 0.107 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 6 Hours | -0.088 mmol/L | Standard Deviation 0.109 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 24 Hours | 0.093 mmol/L | Standard Deviation 0.099 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 21 Hours | 0.315 mmol/L | Standard Deviation 0.132 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 42 Hours | 0.343 mmol/L | Standard Deviation 0.123 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 15 Hours | 0.258 mmol/L | Standard Deviation 0.132 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 1 Hour | -0.067 mmol/L | Standard Deviation 0.124 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 18 Hours | 0.357 mmol/L | Standard Deviation 0.12 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 3 Hours | -0.013 mmol/L | Standard Deviation 0.14 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 30 Minutes | -0.055 mmol/L | Standard Deviation 0.085 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 10 Minutes | 0.007 mmol/L | Standard Deviation 0.094 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 9 Hours | 0.128 mmol/L | Standard Deviation 0.122 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 36 Hours | 0.162 mmol/L | Standard Deviation 0.13 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 30 Hours | 0.085 mmol/L | Standard Deviation 0.137 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 48 Hours | 0.100 mmol/L | Standard Deviation 0.087 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 27 Hours | -0.003 mmol/L | Standard Deviation 0.124 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Phosphate | 12 Hours | 0.043 mmol/L | Standard Deviation 0.123 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 30 Minutes | -0.067 mmol/L | Standard Deviation 0.055 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 3 Hours | 0.005 mmol/L | Standard Deviation 0.096 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 36 Hours | 0.045 mmol/L | Standard Deviation 0.082 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 6 Hours | 0.098 mmol/L | Standard Deviation 0.123 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 9 Hours | 0.100 mmol/L | Standard Deviation 0.118 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 12 Hours | -0.090 mmol/L | Standard Deviation 0.165 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 15 Hours | 0.188 mmol/L | Standard Deviation 0.18 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 42 Hours | 0.342 mmol/L | Standard Deviation 0.076 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 18 Hours | 0.307 mmol/L | Standard Deviation 0.12 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 21 Hours | 0.312 mmol/L | Standard Deviation 0.065 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 24 Hours | 0.053 mmol/L | Standard Deviation 0.079 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 27 Hours | -0.127 mmol/L | Standard Deviation 0.044 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 30 Hours | 0.130 mmol/L | Standard Deviation 0.157 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 10 Minutes | -0.065 mmol/L | Standard Deviation 0.059 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 48 Hours | 0.027 mmol/L | Standard Deviation 0.115 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Phosphate | 1 Hour | -0.058 mmol/L | Standard Deviation 0.039 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 21 Hours | 0.296 mmol/L | Standard Deviation 0.129 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 12 Hours | -0.018 mmol/L | Standard Deviation 0.164 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 24 Hours | 0.158 mmol/L | Standard Deviation 0.126 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 48 Hours | 0.142 mmol/L | Standard Deviation 0.162 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 27 Hours | -0.015 mmol/L | Standard Deviation 0.215 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 9 Hours | 0.162 mmol/L | Standard Deviation 0.135 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 3 Hours | 0.110 mmol/L | Standard Deviation 0.104 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 30 Hours | 0.148 mmol/L | Standard Deviation 0.242 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 36 Hours | 0.072 mmol/L | Standard Deviation 0.106 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 1 Hour | -0.010 mmol/L | Standard Deviation 0.045 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 10 Minutes | -0.010 mmol/L | Standard Deviation 0.031 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 6 Hours | 0.058 mmol/L | Standard Deviation 0.237 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 15 Hours | 0.220 mmol/L | Standard Deviation 0.139 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 30 Minutes | -0.017 mmol/L | Standard Deviation 0.042 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 18 Hours | 0.375 mmol/L | Standard Deviation 0.113 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Phosphate | 42 Hours | 0.398 mmol/L | Standard Deviation 0.222 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 12 Hours | 0.028 mmol/L | Standard Deviation 0.143 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 21 Hours | 0.518 mmol/L | Standard Deviation 0.12 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 42 Hours | 0.480 mmol/L | Standard Deviation 0.235 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 36 Hours | 0.280 mmol/L | Standard Deviation 0.21 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 1 Hour | 0.005 mmol/L | Standard Deviation 0.035 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 18 Hours | 0.538 mmol/L | Standard Deviation 0.1 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 24 Hours | 0.116 mmol/L | Standard Deviation 0.096 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 48 Hours | 0.160 mmol/L | Standard Deviation 0.111 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 30 Minutes | 0.012 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 3 Hours | 0.060 mmol/L | Standard Deviation 0.083 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 10 Minutes | 0.022 mmol/L | Standard Deviation 0.042 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 27 Hours | 0.065 mmol/L | Standard Deviation 0.141 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 9 Hours | 0.275 mmol/L | Standard Deviation 0.126 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 30 Hours | 0.388 mmol/L | Standard Deviation 0.087 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 6 Hours | 0.146 mmol/L | Standard Deviation 0.142 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Phosphate | 15 Hours | 0.355 mmol/L | Standard Deviation 0.141 |
Secondary
Change From Baseline in Serum Total Calcium
Time frame: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose
Population: Modified intent-to-treat population with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 6 Hours | -0.024 mmol/L | Standard Deviation 0.04 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 30 Minutes | -0.018 mmol/L | Standard Deviation 0.036 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 1 Hour | -0.024 mmol/L | Standard Deviation 0.039 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 3 Hours | -0.001 mmol/L | Standard Deviation 0.035 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 10 Minutes | -0.019 mmol/L | Standard Deviation 0.047 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 9 Hours | -0.010 mmol/L | Standard Deviation 0.041 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 12 Hours | -0.055 mmol/L | Standard Deviation 0.038 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 15 Hours | -0.176 mmol/L | Standard Deviation 0.324 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 18 Hours | -0.090 mmol/L | Standard Deviation 0.074 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 21 Hours | -0.058 mmol/L | Standard Deviation 0.038 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 24 Hours | -0.025 mmol/L | Standard Deviation 0.03 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 27 Hours | 0.030 mmol/L | Standard Deviation 0.037 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 30 Hours | -0.003 mmol/L | Standard Deviation 0.036 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 36 Hours | -0.035 mmol/L | Standard Deviation 0.035 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 42 Hours | -0.009 mmol/L | Standard Deviation 0.055 |
| Pooled Placebo | Change From Baseline in Serum Total Calcium | 48 Hours | 0.013 mmol/L | Standard Deviation 0.042 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 36 Hours | -0.002 mmol/L | Standard Deviation 0.074 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 21 Hours | -0.012 mmol/L | Standard Deviation 0.113 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 18 Hours | -0.030 mmol/L | Standard Deviation 0.077 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 42 Hours | -0.033 mmol/L | Standard Deviation 0.085 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 15 Hours | -0.075 mmol/L | Standard Deviation 0.105 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 6 Hours | -0.065 mmol/L | Standard Deviation 0.09 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 3 Hours | -0.018 mmol/L | Standard Deviation 0.074 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 30 Minutes | -0.008 mmol/L | Standard Deviation 0.079 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 10 Minutes | -0.008 mmol/L | Standard Deviation 0.081 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 30 Hours | 0.025 mmol/L | Standard Deviation 0.102 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 9 Hours | -0.122 mmol/L | Standard Deviation 0.117 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 1 Hour | -0.033 mmol/L | Standard Deviation 0.073 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 48 Hours | -0.010 mmol/L | Standard Deviation 0.093 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 27 Hours | 0.020 mmol/L | Standard Deviation 0.106 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 24 Hours | -0.040 mmol/L | Standard Deviation 0.076 |
| Etelcalcetide 0.5 mg | Change From Baseline in Serum Total Calcium | 12 Hours | -0.058 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 36 Hours | -0.058 mmol/L | Standard Deviation 0.084 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 3 Hours | -0.017 mmol/L | Standard Deviation 0.048 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 6 Hours | 0.008 mmol/L | Standard Deviation 0.066 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 9 Hours | -0.120 mmol/L | Standard Deviation 0.218 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 12 Hours | -0.067 mmol/L | Standard Deviation 0.024 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 15 Hours | -0.107 mmol/L | Standard Deviation 0.039 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 42 Hours | 0.002 mmol/L | Standard Deviation 0.029 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 18 Hours | -0.100 mmol/L | Standard Deviation 0.027 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 21 Hours | -0.090 mmol/L | Standard Deviation 0.041 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 24 Hours | -0.038 mmol/L | Standard Deviation 0.061 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 27 Hours | 0.018 mmol/L | Standard Deviation 0.08 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 30 Hours | -0.013 mmol/L | Standard Deviation 0.063 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 10 Minutes | -0.022 mmol/L | Standard Deviation 0.063 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 48 Hours | 0.018 mmol/L | Standard Deviation 0.038 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 30 Minutes | -0.018 mmol/L | Standard Deviation 0.062 |
| Etelcalcetide 2 mg | Change From Baseline in Serum Total Calcium | 1 Hour | -0.023 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 21 Hours | -0.174 mmol/L | Standard Deviation 0.04 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 48 Hours | -0.085 mmol/L | Standard Deviation 0.036 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 24 Hours | -0.200 mmol/L | Standard Deviation 0.036 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 36 Hours | -0.143 mmol/L | Standard Deviation 0.077 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 27 Hours | -0.070 mmol/L | Standard Deviation 0.057 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 9 Hours | -0.126 mmol/L | Standard Deviation 0.043 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 30 Hours | -0.165 mmol/L | Standard Deviation 0.071 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 3 Hours | -0.025 mmol/L | Standard Deviation 0.066 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 10 Minutes | -0.017 mmol/L | Standard Deviation 0.053 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 1 Hour | -0.017 mmol/L | Standard Deviation 0.058 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 15 Hours | -0.243 mmol/L | Standard Deviation 0.064 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 6 Hours | -0.045 mmol/L | Standard Deviation 0.058 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 18 Hours | -0.217 mmol/L | Standard Deviation 0.045 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 42 Hours | -0.100 mmol/L | Standard Deviation 0.021 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 12 Hours | -0.203 mmol/L | Standard Deviation 0.041 |
| Etelcalcetide 5 mg | Change From Baseline in Serum Total Calcium | 30 Minutes | -0.023 mmol/L | Standard Deviation 0.041 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 30 Hours | -0.182 mmol/L | Standard Deviation 0.057 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 21 Hours | -0.285 mmol/L | Standard Deviation 0.039 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 42 Hours | -0.120 mmol/L | Standard Deviation 0.045 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 6 Hours | -0.138 mmol/L | Standard Deviation 0.061 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 30 Minutes | -0.042 mmol/L | Standard Deviation 0.037 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 15 Hours | -0.312 mmol/L | Standard Deviation 0.056 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 24 Hours | -0.270 mmol/L | Standard Deviation 0.072 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 48 Hours | -0.107 mmol/L | Standard Deviation 0.047 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 9 Hours | -0.170 mmol/L | Standard Deviation 0.065 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 18 Hours | -0.328 mmol/L | Standard Deviation 0.075 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 10 Minutes | -0.030 mmol/L | Standard Deviation 0.049 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 27 Hours | -0.165 mmol/L | Standard Deviation 0.058 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 12 Hours | -0.285 mmol/L | Standard Deviation 0.079 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 36 Hours | -0.210 mmol/L | Standard Deviation 0.04 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 3 Hours | -0.050 mmol/L | Standard Deviation 0.032 |
| Etelcalcetide 10 mg | Change From Baseline in Serum Total Calcium | 1 Hour | -0.042 mmol/L | Standard Deviation 0.026 |
Secondary
Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | 19.5 hours | Standard Deviation 1.35 |
| Etelcalcetide 0.5 mg | Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | 20.0 hours | Standard Deviation 2.25 |
| Etelcalcetide 2 mg | Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | 18.6 hours | Standard Deviation 2.51 |
| Etelcalcetide 5 mg | Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | 18.4 hours | Standard Deviation 2.21 |
Secondary
Maximum Observed Concentration (Cmax) for Etelcalcetide
Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Maximum Observed Concentration (Cmax) for Etelcalcetide | 43.5 μg/L | Standard Deviation 7.86 |
| Etelcalcetide 0.5 mg | Maximum Observed Concentration (Cmax) for Etelcalcetide | 171 μg/L | Standard Deviation 35.6 |
| Etelcalcetide 2 mg | Maximum Observed Concentration (Cmax) for Etelcalcetide | 280 μg/L | Standard Deviation 59.3 |
| Etelcalcetide 5 mg | Maximum Observed Concentration (Cmax) for Etelcalcetide | 583 μg/L | Standard Deviation 144 |
Secondary
Number of Participants With Antibodies to Etelcalcetide
Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).
Time frame: Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Antibodies to Etelcalcetide | 0 Participants |
| Etelcalcetide 0.5 mg | Number of Participants With Antibodies to Etelcalcetide | 0 Participants |
| Etelcalcetide 2 mg | Number of Participants With Antibodies to Etelcalcetide | 0 Participants |
| Etelcalcetide 5 mg | Number of Participants With Antibodies to Etelcalcetide | 0 Participants |
Secondary
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 94.3 hr*μg/L | Standard Deviation 12.5 |
| Etelcalcetide 0.5 mg | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 294 hr*μg/L | Standard Deviation 34.1 |
| Etelcalcetide 2 mg | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 623 hr*μg/L | Standard Deviation 71.5 |
| Etelcalcetide 5 mg | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | 1290 hr*μg/L | Standard Deviation 116 |
Secondary
Percent Change From Baseline in Plasma Ionized Calcium
Time frame: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose
Population: Modified intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 6 Hours | -1.79 percent change | Standard Deviation 3.32 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 30 Minutes | -1.27 percent change | Standard Deviation 3.67 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 1 Hour | -1.15 percent change | Standard Deviation 4.62 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 3 Hours | -1.72 percent change | Standard Deviation 4.85 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 10 Minutes | -1.48 percent change | Standard Deviation 3.55 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 9 Hours | -4.68 percent change | Standard Deviation 3.76 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 12 Hours | -7.14 percent change | Standard Deviation 3.93 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 15 Hours | -3.71 percent change | Standard Deviation 4.25 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 18 Hours | -3.38 percent change | Standard Deviation 4.24 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 21 Hours | -1.11 percent change | Standard Deviation 3.56 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 24 Hours | -0.70 percent change | Standard Deviation 4.64 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 27 Hours | -1.78 percent change | Standard Deviation 4.12 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 30 Hours | 0.17 percent change | Standard Deviation 4.11 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 36 Hours | -5.02 percent change | Standard Deviation 5.4 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 42 Hours | -1.38 percent change | Standard Deviation 3.56 |
| Pooled Placebo | Percent Change From Baseline in Plasma Ionized Calcium | 48 Hours | 2.12 percent change | Standard Deviation 4.24 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 36 Hours | -3.28 percent change | Standard Deviation 5.39 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 21 Hours | 3.90 percent change | Standard Deviation 3.6 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 18 Hours | -1.62 percent change | Standard Deviation 5.07 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 42 Hours | 0.55 percent change | Standard Deviation 3.44 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 15 Hours | -2.53 percent change | Standard Deviation 2.98 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 6 Hours | -1.36 percent change | Standard Deviation 2.66 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 3 Hours | 0.73 percent change | Standard Deviation 1.4 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Minutes | -0.51 percent change | Standard Deviation 3.54 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 10 Minutes | 0.98 percent change | Standard Deviation 2.79 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Hours | 2.51 percent change | Standard Deviation 3.84 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 9 Hours | -3.39 percent change | Standard Deviation 5 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 1 Hour | 1.15 percent change | Standard Deviation 3.08 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 48 Hours | 2.17 percent change | Standard Deviation 2.91 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 27 Hours | 2.62 percent change | Standard Deviation 3.73 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 24 Hours | 3.77 percent change | Standard Deviation 1.93 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 12 Hours | -2.83 percent change | Standard Deviation 3.22 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 36 Hours | -7.68 percent change | Standard Deviation 3.35 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 3 Hours | -5.86 percent change | Standard Deviation 2.52 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 6 Hours | -4.88 percent change | Standard Deviation 2.58 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 9 Hours | -9.51 percent change | Standard Deviation 5.4 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 12 Hours | -9.54 percent change | Standard Deviation 2.17 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 15 Hours | -10.41 percent change | Standard Deviation 1.32 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 42 Hours | 0.14 percent change | Standard Deviation 1.32 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 18 Hours | -9.00 percent change | Standard Deviation 1.18 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 21 Hours | -6.38 percent change | Standard Deviation 1.74 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 24 Hours | -2.45 percent change | Standard Deviation 1.95 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 27 Hours | -6.26 percent change | Standard Deviation 2.74 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Hours | -5.82 percent change | Standard Deviation 2.06 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 10 Minutes | -3.94 percent change | Standard Deviation 2.33 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 48 Hours | -0.42 percent change | Standard Deviation 1.83 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Minutes | -2.46 percent change | Standard Deviation 3.2 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Plasma Ionized Calcium | 1 Hour | -4.50 percent change | Standard Deviation 2.65 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 21 Hours | -13.97 percent change | Standard Deviation 2.48 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 48 Hours | -6.22 percent change | Standard Deviation 3.17 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 24 Hours | -11.83 percent change | Standard Deviation 4.46 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 36 Hours | -13.69 percent change | Standard Deviation 4.43 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 27 Hours | -7.71 percent change | Standard Deviation 2.28 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 9 Hours | -16.45 percent change | Standard Deviation 2.55 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Hours | -9.65 percent change | Standard Deviation 2.73 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 3 Hours | -6.65 percent change | Standard Deviation 2.31 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 10 Minutes | -5.30 percent change | Standard Deviation 2.13 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 1 Hour | -4.12 percent change | Standard Deviation 2.08 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 15 Hours | -15.38 percent change | Standard Deviation 3.05 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 6 Hours | -9.95 percent change | Standard Deviation 1.91 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 18 Hours | -14.33 percent change | Standard Deviation 2.31 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 42 Hours | -5.92 percent change | Standard Deviation 3.3 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 12 Hours | -15.27 percent change | Standard Deviation 1.49 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Minutes | -6.87 percent change | Standard Deviation 2.06 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Hours | -11.78 percent change | Standard Deviation 5.66 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 21 Hours | -11.77 percent change | Standard Deviation 1.85 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 42 Hours | -3.40 percent change | Standard Deviation 3.07 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 6 Hours | -2.84 percent change | Standard Deviation 2.67 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 30 Minutes | 1.18 percent change | Standard Deviation 2.92 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 15 Hours | -11.74 percent change | Standard Deviation 4.08 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 24 Hours | -11.59 percent change | Standard Deviation 4.49 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 48 Hours | -0.39 percent change | Standard Deviation 2.85 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 9 Hours | -9.54 percent change | Standard Deviation 5.32 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 18 Hours | -12.34 percent change | Standard Deviation 3.27 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 10 Minutes | -2.47 percent change | Standard Deviation 2.79 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 27 Hours | -7.89 percent change | Standard Deviation 1.46 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 12 Hours | -14.92 percent change | Standard Deviation 5.47 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 36 Hours | -9.45 percent change | Standard Deviation 3.11 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 3 Hours | -1.83 percent change | Standard Deviation 4.07 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Plasma Ionized Calcium | 1 Hour | -3.27 percent change | Standard Deviation 1.52 |
Secondary
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
Time frame: Baseline and 12, 24, and 48 hours post-dose
Population: Modified intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 12 Hours | -14.46 percent change | Standard Deviation 5.49 |
| Pooled Placebo | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 48 Hours | -4.32 percent change | Standard Deviation 11.22 |
| Pooled Placebo | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 24 Hours | -0.61 percent change | Standard Deviation 13.13 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 24 Hours | 3.16 percent change | Standard Deviation 16.23 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 12 Hours | -4.64 percent change | Standard Deviation 12.06 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 48 Hours | 0.09 percent change | Standard Deviation 19.03 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 24 Hours | 4.16 percent change | Standard Deviation 17.23 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 12 Hours | -6.12 percent change | Standard Deviation 19.16 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 48 Hours | 5.99 percent change | Standard Deviation 18.81 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 12 Hours | -18.43 percent change | Standard Deviation 9.44 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 48 Hours | 0.61 percent change | Standard Deviation 11.49 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 24 Hours | -0.54 percent change | Standard Deviation 15.12 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 24 Hours | -14.51 percent change | Standard Deviation 7.11 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 12 Hours | -25.60 percent change | Standard Deviation 7.9 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | 48 Hours | -3.53 percent change | Standard Deviation 16.54 |
Secondary
Percent Change From Baseline in Serum Calcitonin
Time frame: Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
Population: Modified intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Serum Calcitonin | 10 Minutes | 15.92 percent change | Standard Deviation 50.25 |
| Pooled Placebo | Percent Change From Baseline in Serum Calcitonin | 30 Minutes | 17.41 percent change | Standard Deviation 57.12 |
| Pooled Placebo | Percent Change From Baseline in Serum Calcitonin | 3 Hours | 11.48 percent change | Standard Deviation 25.51 |
| Pooled Placebo | Percent Change From Baseline in Serum Calcitonin | 12 Hours | 12.14 percent change | Standard Deviation 52.58 |
| Pooled Placebo | Percent Change From Baseline in Serum Calcitonin | 24 Hours | 15.51 percent change | Standard Deviation 61.1 |
| Pooled Placebo | Percent Change From Baseline in Serum Calcitonin | 48 Hours | 26.42 percent change | Standard Deviation 74.89 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Calcitonin | 24 Hours | -1.11 percent change | Standard Deviation 2.72 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Calcitonin | 48 Hours | 5.00 percent change | Standard Deviation 12.25 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Calcitonin | 10 Minutes | 9.18 percent change | Standard Deviation 14.47 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Calcitonin | 3 Hours | 3.33 percent change | Standard Deviation 8.16 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Calcitonin | 12 Hours | 10.56 percent change | Standard Deviation 25.86 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Calcitonin | 30 Minutes | 16.72 percent change | Standard Deviation 29.86 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Calcitonin | 12 Hours | -5.07 percent change | Standard Deviation 12.42 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Calcitonin | 24 Hours | -5.07 percent change | Standard Deviation 12.42 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Calcitonin | 10 Minutes | -5.07 percent change | Standard Deviation 12.42 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Calcitonin | 3 Hours | -0.78 percent change | Standard Deviation 17.8 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Calcitonin | 30 Minutes | 8.20 percent change | Standard Deviation 37.05 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Calcitonin | 48 Hours | -5.07 percent change | Standard Deviation 12.42 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Calcitonin | 12 Hours | -10.89 percent change | Standard Deviation 17.56 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Calcitonin | 30 Minutes | 24.39 percent change | Standard Deviation 33.5 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Calcitonin | 3 Hours | 3.12 percent change | Standard Deviation 20.84 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Calcitonin | 48 Hours | 0.53 percent change | Standard Deviation 16.81 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Calcitonin | 24 Hours | -13.45 percent change | Standard Deviation 20.84 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Calcitonin | 10 Minutes | 15.44 percent change | Standard Deviation 29.09 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Calcitonin | 24 Hours | -4.69 percent change | Standard Deviation 11.48 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Calcitonin | 3 Hours | 47.81 percent change | Standard Deviation 109.64 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Calcitonin | 30 Minutes | 77.35 percent change | Standard Deviation 143.22 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Calcitonin | 48 Hours | 31.58 percent change | Standard Deviation 88.51 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Calcitonin | 12 Hours | 9.71 percent change | Standard Deviation 28.64 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Calcitonin | 10 Minutes | 51.45 percent change | Standard Deviation 119.74 |
Secondary
Percent Change From Baseline in Serum Parathyroid Hormone
Time frame: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose
Population: Modified intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 6 Hours | -2.57 percent change | Standard Deviation 30.28 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Minutes | -3.52 percent change | Standard Deviation 16.29 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 1 Hour | 1.11 percent change | Standard Deviation 12.85 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 3 Hours | 1.76 percent change | Standard Deviation 26.67 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 10 Minutes | 4.57 percent change | Standard Deviation 15.42 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 9 Hours | 19.87 percent change | Standard Deviation 25.16 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 12 Hours | 30.49 percent change | Standard Deviation 28.14 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 15 Hours | 31.97 percent change | Standard Deviation 25.22 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 18 Hours | 27.21 percent change | Standard Deviation 15.21 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 21 Hours | 9.65 percent change | Standard Deviation 16.08 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 24 Hours | -9.50 percent change | Standard Deviation 16.2 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 27 Hours | -21.56 percent change | Standard Deviation 11.39 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Hours | 10.58 percent change | Standard Deviation 15.51 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 36 Hours | 25.24 percent change | Standard Deviation 20.51 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 42 Hours | 6.15 percent change | Standard Deviation 26.47 |
| Pooled Placebo | Percent Change From Baseline in Serum Parathyroid Hormone | 48 Hours | -13.90 percent change | Standard Deviation 15.92 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 36 Hours | 18.19 percent change | Standard Deviation 25.35 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 21 Hours | -0.67 percent change | Standard Deviation 20.04 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 18 Hours | -6.22 percent change | Standard Deviation 11.89 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 42 Hours | 3.28 percent change | Standard Deviation 11.15 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 15 Hours | 4.17 percent change | Standard Deviation 19.38 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 6 Hours | 7.01 percent change | Standard Deviation 10.64 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 3 Hours | -5.95 percent change | Standard Deviation 7.62 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Minutes | -21.74 percent change | Standard Deviation 9.55 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 10 Minutes | -20.58 percent change | Standard Deviation 4.25 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Hours | -8.19 percent change | Standard Deviation 14.9 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 9 Hours | 46.50 percent change | Standard Deviation 27.97 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 1 Hour | -18.71 percent change | Standard Deviation 11.68 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 48 Hours | -10.39 percent change | Standard Deviation 12.66 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 27 Hours | -27.97 percent change | Standard Deviation 10.32 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 24 Hours | -1.72 percent change | Standard Deviation 22.4 |
| Etelcalcetide 0.5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 12 Hours | 8.07 percent change | Standard Deviation 17.54 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 36 Hours | 20.63 percent change | Standard Deviation 34.27 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 3 Hours | -39.87 percent change | Standard Deviation 10.87 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 6 Hours | -41.56 percent change | Standard Deviation 12.03 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 9 Hours | 12.54 percent change | Standard Deviation 40.52 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 12 Hours | 5.04 percent change | Standard Deviation 27.93 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 15 Hours | 20.06 percent change | Standard Deviation 39.27 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 42 Hours | 1.49 percent change | Standard Deviation 23.88 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 18 Hours | 25.91 percent change | Standard Deviation 28.39 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 21 Hours | 22.04 percent change | Standard Deviation 16.74 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 24 Hours | -14.65 percent change | Standard Deviation 13.43 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 27 Hours | -34.76 percent change | Standard Deviation 13.58 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Hours | 1.21 percent change | Standard Deviation 21.7 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 10 Minutes | -45.09 percent change | Standard Deviation 9.31 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 48 Hours | -4.86 percent change | Standard Deviation 26.04 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Minutes | -55.42 percent change | Standard Deviation 4.31 |
| Etelcalcetide 2 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 1 Hour | -47.16 percent change | Standard Deviation 7.94 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 21 Hours | -2.10 percent change | Standard Deviation 25.36 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 48 Hours | -24.02 percent change | Standard Deviation 15 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 24 Hours | -19.25 percent change | Standard Deviation 17.66 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 36 Hours | 17.61 percent change | Standard Deviation 37.53 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 27 Hours | -49.48 percent change | Standard Deviation 12.23 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 9 Hours | -40.79 percent change | Standard Deviation 15.91 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Hours | -11.15 percent change | Standard Deviation 23.59 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 3 Hours | -62.56 percent change | Standard Deviation 13.3 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 10 Minutes | -59.38 percent change | Standard Deviation 8.89 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 1 Hour | -67.72 percent change | Standard Deviation 10.84 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 15 Hours | -2.33 percent change | Standard Deviation 21.12 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 6 Hours | -60.87 percent change | Standard Deviation 13.41 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 18 Hours | 2.19 percent change | Standard Deviation 20.72 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 42 Hours | -19.21 percent change | Standard Deviation 20.33 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 12 Hours | -24.05 percent change | Standard Deviation 13.94 |
| Etelcalcetide 5 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Minutes | -69.00 percent change | Standard Deviation 7.02 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Hours | -25.32 percent change | Standard Deviation 12.63 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 21 Hours | -4.02 percent change | Standard Deviation 19.11 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 42 Hours | -29.37 percent change | Standard Deviation 21.78 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 6 Hours | -66.68 percent change | Standard Deviation 10.41 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 30 Minutes | -72.56 percent change | Standard Deviation 6.33 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 15 Hours | -24.31 percent change | Standard Deviation 17.06 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 24 Hours | -18.34 percent change | Standard Deviation 15.17 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 48 Hours | -10.84 percent change | Standard Deviation 20.6 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 9 Hours | -54.43 percent change | Standard Deviation 12.97 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 18 Hours | -15.78 percent change | Standard Deviation 13.66 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 10 Minutes | -63.31 percent change | Standard Deviation 8.11 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 27 Hours | -37.15 percent change | Standard Deviation 18.99 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 12 Hours | -40.28 percent change | Standard Deviation 19.35 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 36 Hours | 1.08 percent change | Standard Deviation 27.77 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 3 Hours | -69.70 percent change | Standard Deviation 7.62 |
| Etelcalcetide 10 mg | Percent Change From Baseline in Serum Parathyroid Hormone | 1 Hour | -73.29 percent change | Standard Deviation 6.97 |
Secondary
Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | 14.0 percentage of AUCINFobs | Standard Deviation 1.33 |
| Etelcalcetide 0.5 mg | Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | 13.2 percentage of AUCINFobs | Standard Deviation 2.57 |
| Etelcalcetide 2 mg | Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | 12.6 percentage of AUCINFobs | Standard Deviation 2.43 |
| Etelcalcetide 5 mg | Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | 12.0 percentage of AUCINFobs | Standard Deviation 2.79 |
Secondary
Terminal Elimination Rate Constant (λz) for Etelcalcetide
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Terminal Elimination Rate Constant (λz) for Etelcalcetide | 0.0357 1/hr | Standard Deviation 0.00246 |
| Etelcalcetide 0.5 mg | Terminal Elimination Rate Constant (λz) for Etelcalcetide | 0.0349 1/hr | Standard Deviation 0.00337 |
| Etelcalcetide 2 mg | Terminal Elimination Rate Constant (λz) for Etelcalcetide | 0.0378 1/hr | Standard Deviation 0.00486 |
| Etelcalcetide 5 mg | Terminal Elimination Rate Constant (λz) for Etelcalcetide | 0.0382 1/hr | Standard Deviation 0.00539 |
Secondary
Total Body Clearance (CL) for Etelcalcetide
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Total Body Clearance (CL) for Etelcalcetide | 5.38 L/hr | Standard Deviation 0.675 |
| Etelcalcetide 0.5 mg | Total Body Clearance (CL) for Etelcalcetide | 6.87 L/hr | Standard Deviation 0.75 |
| Etelcalcetide 2 mg | Total Body Clearance (CL) for Etelcalcetide | 8.11 L/hr | Standard Deviation 0.928 |
| Etelcalcetide 5 mg | Total Body Clearance (CL) for Etelcalcetide | 7.83 L/hr | Standard Deviation 0.755 |
Secondary
Volume of Distribution at Steady State for Etelcalcetide
Time frame: Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.
Population: Participants who received etelcalcetide
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Volume of Distribution at Steady State for Etelcalcetide | 113 liters | Standard Deviation 19.6 |
| Etelcalcetide 0.5 mg | Volume of Distribution at Steady State for Etelcalcetide | 138 liters | Standard Deviation 26 |
| Etelcalcetide 2 mg | Volume of Distribution at Steady State for Etelcalcetide | 160 liters | Standard Deviation 21 |
| Etelcalcetide 5 mg | Volume of Distribution at Steady State for Etelcalcetide | 152 liters | Standard Deviation 30 |