Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers (NCT NCT01134549)
NCT ID: NCT01134549
Last Updated: 2017-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
From the first dose of study drug through 7 days.
Results posted on
2017-04-14
Participant Flow
This study was conducted at one clinical center in Australia.
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.
Participant milestones
| Measure |
Pooled Placebo
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
22.4 years
STANDARD_DEVIATION 3.5 • n=99 Participants
|
27.8 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
26.8 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
24.2 years
STANDARD_DEVIATION 4.4 • n=157 Participants
|
26.0 years
STANDARD_DEVIATION 6.2 • n=390 Participants
|
25.3 years
STANDARD_DEVIATION 5.7 • n=16 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
32 Participants
n=16 Participants
|
|
Race
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
23 Participants
n=16 Participants
|
|
Race
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
8 Participants
n=16 Participants
|
|
Race
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
|
Ethnicity
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
31 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Withdrawals due to adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dosePopulation: Modified intent-to-treat population
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Parathyroid Hormone
27 Hours
|
-21.56 percent change
Standard Deviation 11.39
|
-27.97 percent change
Standard Deviation 10.32
|
-34.76 percent change
Standard Deviation 13.58
|
-49.48 percent change
Standard Deviation 12.23
|
-37.15 percent change
Standard Deviation 18.99
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
30 Hours
|
10.58 percent change
Standard Deviation 15.51
|
-8.19 percent change
Standard Deviation 14.90
|
1.21 percent change
Standard Deviation 21.70
|
-11.15 percent change
Standard Deviation 23.59
|
-25.32 percent change
Standard Deviation 12.63
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
36 Hours
|
25.24 percent change
Standard Deviation 20.51
|
18.19 percent change
Standard Deviation 25.35
|
20.63 percent change
Standard Deviation 34.27
|
17.61 percent change
Standard Deviation 37.53
|
1.08 percent change
Standard Deviation 27.77
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
10 Minutes
|
4.57 percent change
Standard Deviation 15.42
|
-20.58 percent change
Standard Deviation 4.25
|
-45.09 percent change
Standard Deviation 9.31
|
-59.38 percent change
Standard Deviation 8.89
|
-63.31 percent change
Standard Deviation 8.11
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
30 Minutes
|
-3.52 percent change
Standard Deviation 16.29
|
-21.74 percent change
Standard Deviation 9.55
|
-55.42 percent change
Standard Deviation 4.31
|
-69.00 percent change
Standard Deviation 7.02
|
-72.56 percent change
Standard Deviation 6.33
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
1 Hour
|
1.11 percent change
Standard Deviation 12.85
|
-18.71 percent change
Standard Deviation 11.68
|
-47.16 percent change
Standard Deviation 7.94
|
-67.72 percent change
Standard Deviation 10.84
|
-73.29 percent change
Standard Deviation 6.97
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
3 Hours
|
1.76 percent change
Standard Deviation 26.67
|
-5.95 percent change
Standard Deviation 7.62
|
-39.87 percent change
Standard Deviation 10.87
|
-62.56 percent change
Standard Deviation 13.30
|
-69.70 percent change
Standard Deviation 7.62
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
6 Hours
|
-2.57 percent change
Standard Deviation 30.28
|
7.01 percent change
Standard Deviation 10.64
|
-41.56 percent change
Standard Deviation 12.03
|
-60.87 percent change
Standard Deviation 13.41
|
-66.68 percent change
Standard Deviation 10.41
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
9 Hours
|
19.87 percent change
Standard Deviation 25.16
|
46.50 percent change
Standard Deviation 27.97
|
12.54 percent change
Standard Deviation 40.52
|
-40.79 percent change
Standard Deviation 15.91
|
-54.43 percent change
Standard Deviation 12.97
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
12 Hours
|
30.49 percent change
Standard Deviation 28.14
|
8.07 percent change
Standard Deviation 17.54
|
5.04 percent change
Standard Deviation 27.93
|
-24.05 percent change
Standard Deviation 13.94
|
-40.28 percent change
Standard Deviation 19.35
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
15 Hours
|
31.97 percent change
Standard Deviation 25.22
|
4.17 percent change
Standard Deviation 19.38
|
20.06 percent change
Standard Deviation 39.27
|
-2.33 percent change
Standard Deviation 21.12
|
-24.31 percent change
Standard Deviation 17.06
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
18 Hours
|
27.21 percent change
Standard Deviation 15.21
|
-6.22 percent change
Standard Deviation 11.89
|
25.91 percent change
Standard Deviation 28.39
|
2.19 percent change
Standard Deviation 20.72
|
-15.78 percent change
Standard Deviation 13.66
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
21 Hours
|
9.65 percent change
Standard Deviation 16.08
|
-0.67 percent change
Standard Deviation 20.04
|
22.04 percent change
Standard Deviation 16.74
|
-2.10 percent change
Standard Deviation 25.36
|
-4.02 percent change
Standard Deviation 19.11
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
24 Hours
|
-9.50 percent change
Standard Deviation 16.20
|
-1.72 percent change
Standard Deviation 22.40
|
-14.65 percent change
Standard Deviation 13.43
|
-19.25 percent change
Standard Deviation 17.66
|
-18.34 percent change
Standard Deviation 15.17
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
42 Hours
|
6.15 percent change
Standard Deviation 26.47
|
3.28 percent change
Standard Deviation 11.15
|
1.49 percent change
Standard Deviation 23.88
|
-19.21 percent change
Standard Deviation 20.33
|
-29.37 percent change
Standard Deviation 21.78
|
|
Percent Change From Baseline in Serum Parathyroid Hormone
48 Hours
|
-13.90 percent change
Standard Deviation 15.92
|
-10.39 percent change
Standard Deviation 12.66
|
-4.86 percent change
Standard Deviation 26.04
|
-24.02 percent change
Standard Deviation 15.00
|
-10.84 percent change
Standard Deviation 20.60
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dosePopulation: Modified intent-to-treat population
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Plasma Ionized Calcium
30 Minutes
|
-1.27 percent change
Standard Deviation 3.67
|
-0.51 percent change
Standard Deviation 3.54
|
-2.46 percent change
Standard Deviation 3.20
|
-6.87 percent change
Standard Deviation 2.06
|
1.18 percent change
Standard Deviation 2.92
|
|
Percent Change From Baseline in Plasma Ionized Calcium
1 Hour
|
-1.15 percent change
Standard Deviation 4.62
|
1.15 percent change
Standard Deviation 3.08
|
-4.50 percent change
Standard Deviation 2.65
|
-4.12 percent change
Standard Deviation 2.08
|
-3.27 percent change
Standard Deviation 1.52
|
|
Percent Change From Baseline in Plasma Ionized Calcium
9 Hours
|
-4.68 percent change
Standard Deviation 3.76
|
-3.39 percent change
Standard Deviation 5.00
|
-9.51 percent change
Standard Deviation 5.40
|
-16.45 percent change
Standard Deviation 2.55
|
-9.54 percent change
Standard Deviation 5.32
|
|
Percent Change From Baseline in Plasma Ionized Calcium
18 Hours
|
-3.38 percent change
Standard Deviation 4.24
|
-1.62 percent change
Standard Deviation 5.07
|
-9.00 percent change
Standard Deviation 1.18
|
-14.33 percent change
Standard Deviation 2.31
|
-12.34 percent change
Standard Deviation 3.27
|
|
Percent Change From Baseline in Plasma Ionized Calcium
21 Hours
|
-1.11 percent change
Standard Deviation 3.56
|
3.90 percent change
Standard Deviation 3.60
|
-6.38 percent change
Standard Deviation 1.74
|
-13.97 percent change
Standard Deviation 2.48
|
-11.77 percent change
Standard Deviation 1.85
|
|
Percent Change From Baseline in Plasma Ionized Calcium
48 Hours
|
2.12 percent change
Standard Deviation 4.24
|
2.17 percent change
Standard Deviation 2.91
|
-0.42 percent change
Standard Deviation 1.83
|
-6.22 percent change
Standard Deviation 3.17
|
-0.39 percent change
Standard Deviation 2.85
|
|
Percent Change From Baseline in Plasma Ionized Calcium
10 Minutes
|
-1.48 percent change
Standard Deviation 3.55
|
0.98 percent change
Standard Deviation 2.79
|
-3.94 percent change
Standard Deviation 2.33
|
-5.30 percent change
Standard Deviation 2.13
|
-2.47 percent change
Standard Deviation 2.79
|
|
Percent Change From Baseline in Plasma Ionized Calcium
3 Hours
|
-1.72 percent change
Standard Deviation 4.85
|
0.73 percent change
Standard Deviation 1.40
|
-5.86 percent change
Standard Deviation 2.52
|
-6.65 percent change
Standard Deviation 2.31
|
-1.83 percent change
Standard Deviation 4.07
|
|
Percent Change From Baseline in Plasma Ionized Calcium
6 Hours
|
-1.79 percent change
Standard Deviation 3.32
|
-1.36 percent change
Standard Deviation 2.66
|
-4.88 percent change
Standard Deviation 2.58
|
-9.95 percent change
Standard Deviation 1.91
|
-2.84 percent change
Standard Deviation 2.67
|
|
Percent Change From Baseline in Plasma Ionized Calcium
12 Hours
|
-7.14 percent change
Standard Deviation 3.93
|
-2.83 percent change
Standard Deviation 3.22
|
-9.54 percent change
Standard Deviation 2.17
|
-15.27 percent change
Standard Deviation 1.49
|
-14.92 percent change
Standard Deviation 5.47
|
|
Percent Change From Baseline in Plasma Ionized Calcium
15 Hours
|
-3.71 percent change
Standard Deviation 4.25
|
-2.53 percent change
Standard Deviation 2.98
|
-10.41 percent change
Standard Deviation 1.32
|
-15.38 percent change
Standard Deviation 3.05
|
-11.74 percent change
Standard Deviation 4.08
|
|
Percent Change From Baseline in Plasma Ionized Calcium
24 Hours
|
-0.70 percent change
Standard Deviation 4.64
|
3.77 percent change
Standard Deviation 1.93
|
-2.45 percent change
Standard Deviation 1.95
|
-11.83 percent change
Standard Deviation 4.46
|
-11.59 percent change
Standard Deviation 4.49
|
|
Percent Change From Baseline in Plasma Ionized Calcium
27 Hours
|
-1.78 percent change
Standard Deviation 4.12
|
2.62 percent change
Standard Deviation 3.73
|
-6.26 percent change
Standard Deviation 2.74
|
-7.71 percent change
Standard Deviation 2.28
|
-7.89 percent change
Standard Deviation 1.46
|
|
Percent Change From Baseline in Plasma Ionized Calcium
30 Hours
|
0.17 percent change
Standard Deviation 4.11
|
2.51 percent change
Standard Deviation 3.84
|
-5.82 percent change
Standard Deviation 2.06
|
-9.65 percent change
Standard Deviation 2.73
|
-11.78 percent change
Standard Deviation 5.66
|
|
Percent Change From Baseline in Plasma Ionized Calcium
36 Hours
|
-5.02 percent change
Standard Deviation 5.40
|
-3.28 percent change
Standard Deviation 5.39
|
-7.68 percent change
Standard Deviation 3.35
|
-13.69 percent change
Standard Deviation 4.43
|
-9.45 percent change
Standard Deviation 3.11
|
|
Percent Change From Baseline in Plasma Ionized Calcium
42 Hours
|
-1.38 percent change
Standard Deviation 3.56
|
0.55 percent change
Standard Deviation 3.44
|
0.14 percent change
Standard Deviation 1.32
|
-5.92 percent change
Standard Deviation 3.30
|
-3.40 percent change
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dosePopulation: Modified intent-to-treat population with available data at each time point
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Total Calcium
10 Minutes
|
-0.019 mmol/L
Standard Deviation 0.047
|
-0.008 mmol/L
Standard Deviation 0.081
|
-0.022 mmol/L
Standard Deviation 0.063
|
-0.017 mmol/L
Standard Deviation 0.053
|
-0.030 mmol/L
Standard Deviation 0.049
|
|
Change From Baseline in Serum Total Calcium
12 Hours
|
-0.055 mmol/L
Standard Deviation 0.038
|
-0.058 mmol/L
Standard Deviation 0.080
|
-0.067 mmol/L
Standard Deviation 0.024
|
-0.203 mmol/L
Standard Deviation 0.041
|
-0.285 mmol/L
Standard Deviation 0.079
|
|
Change From Baseline in Serum Total Calcium
15 Hours
|
-0.176 mmol/L
Standard Deviation 0.324
|
-0.075 mmol/L
Standard Deviation 0.105
|
-0.107 mmol/L
Standard Deviation 0.039
|
-0.243 mmol/L
Standard Deviation 0.064
|
-0.312 mmol/L
Standard Deviation 0.056
|
|
Change From Baseline in Serum Total Calcium
30 Minutes
|
-0.018 mmol/L
Standard Deviation 0.036
|
-0.008 mmol/L
Standard Deviation 0.079
|
-0.018 mmol/L
Standard Deviation 0.062
|
-0.023 mmol/L
Standard Deviation 0.041
|
-0.042 mmol/L
Standard Deviation 0.037
|
|
Change From Baseline in Serum Total Calcium
1 Hour
|
-0.024 mmol/L
Standard Deviation 0.039
|
-0.033 mmol/L
Standard Deviation 0.073
|
-0.023 mmol/L
Standard Deviation 0.056
|
-0.017 mmol/L
Standard Deviation 0.058
|
-0.042 mmol/L
Standard Deviation 0.026
|
|
Change From Baseline in Serum Total Calcium
3 Hours
|
-0.001 mmol/L
Standard Deviation 0.035
|
-0.018 mmol/L
Standard Deviation 0.074
|
-0.017 mmol/L
Standard Deviation 0.048
|
-0.025 mmol/L
Standard Deviation 0.066
|
-0.050 mmol/L
Standard Deviation 0.032
|
|
Change From Baseline in Serum Total Calcium
6 Hours
|
-0.024 mmol/L
Standard Deviation 0.040
|
-0.065 mmol/L
Standard Deviation 0.090
|
0.008 mmol/L
Standard Deviation 0.066
|
-0.045 mmol/L
Standard Deviation 0.058
|
-0.138 mmol/L
Standard Deviation 0.061
|
|
Change From Baseline in Serum Total Calcium
9 Hours
|
-0.010 mmol/L
Standard Deviation 0.041
|
-0.122 mmol/L
Standard Deviation 0.117
|
-0.120 mmol/L
Standard Deviation 0.218
|
-0.126 mmol/L
Standard Deviation 0.043
|
-0.170 mmol/L
Standard Deviation 0.065
|
|
Change From Baseline in Serum Total Calcium
18 Hours
|
-0.090 mmol/L
Standard Deviation 0.074
|
-0.030 mmol/L
Standard Deviation 0.077
|
-0.100 mmol/L
Standard Deviation 0.027
|
-0.217 mmol/L
Standard Deviation 0.045
|
-0.328 mmol/L
Standard Deviation 0.075
|
|
Change From Baseline in Serum Total Calcium
21 Hours
|
-0.058 mmol/L
Standard Deviation 0.038
|
-0.012 mmol/L
Standard Deviation 0.113
|
-0.090 mmol/L
Standard Deviation 0.041
|
-0.174 mmol/L
Standard Deviation 0.040
|
-0.285 mmol/L
Standard Deviation 0.039
|
|
Change From Baseline in Serum Total Calcium
24 Hours
|
-0.025 mmol/L
Standard Deviation 0.030
|
-0.040 mmol/L
Standard Deviation 0.076
|
-0.038 mmol/L
Standard Deviation 0.061
|
-0.200 mmol/L
Standard Deviation 0.036
|
-0.270 mmol/L
Standard Deviation 0.072
|
|
Change From Baseline in Serum Total Calcium
27 Hours
|
0.030 mmol/L
Standard Deviation 0.037
|
0.020 mmol/L
Standard Deviation 0.106
|
0.018 mmol/L
Standard Deviation 0.080
|
-0.070 mmol/L
Standard Deviation 0.057
|
-0.165 mmol/L
Standard Deviation 0.058
|
|
Change From Baseline in Serum Total Calcium
30 Hours
|
-0.003 mmol/L
Standard Deviation 0.036
|
0.025 mmol/L
Standard Deviation 0.102
|
-0.013 mmol/L
Standard Deviation 0.063
|
-0.165 mmol/L
Standard Deviation 0.071
|
-0.182 mmol/L
Standard Deviation 0.057
|
|
Change From Baseline in Serum Total Calcium
36 Hours
|
-0.035 mmol/L
Standard Deviation 0.035
|
-0.002 mmol/L
Standard Deviation 0.074
|
-0.058 mmol/L
Standard Deviation 0.084
|
-0.143 mmol/L
Standard Deviation 0.077
|
-0.210 mmol/L
Standard Deviation 0.040
|
|
Change From Baseline in Serum Total Calcium
42 Hours
|
-0.009 mmol/L
Standard Deviation 0.055
|
-0.033 mmol/L
Standard Deviation 0.085
|
0.002 mmol/L
Standard Deviation 0.029
|
-0.100 mmol/L
Standard Deviation 0.021
|
-0.120 mmol/L
Standard Deviation 0.045
|
|
Change From Baseline in Serum Total Calcium
48 Hours
|
0.013 mmol/L
Standard Deviation 0.042
|
-0.010 mmol/L
Standard Deviation 0.093
|
0.018 mmol/L
Standard Deviation 0.038
|
-0.085 mmol/L
Standard Deviation 0.036
|
-0.107 mmol/L
Standard Deviation 0.047
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dosePopulation: Modified intent-to-treat population with available data at each time point
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Corrected Calcium
30 Hours
|
0.008 mmol/L
Standard Deviation 0.035
|
0.035 mmol/L
Standard Deviation 0.078
|
0.007 mmol/L
Standard Deviation 0.046
|
-0.125 mmol/L
Standard Deviation 0.067
|
-0.138 mmol/L
Standard Deviation 0.064
|
|
Change From Baseline in Serum Corrected Calcium
36 Hours
|
-0.025 mmol/L
Standard Deviation 0.037
|
0.008 mmol/L
Standard Deviation 0.046
|
-0.038 mmol/L
Standard Deviation 0.081
|
-0.103 mmol/L
Standard Deviation 0.068
|
-0.157 mmol/L
Standard Deviation 0.051
|
|
Change From Baseline in Serum Corrected Calcium
42 Hours
|
0.001 mmol/L
Standard Deviation 0.060
|
-0.023 mmol/L
Standard Deviation 0.061
|
0.022 mmol/L
Standard Deviation 0.026
|
-0.056 mmol/L
Standard Deviation 0.021
|
-0.067 mmol/L
Standard Deviation 0.036
|
|
Change From Baseline in Serum Corrected Calcium
48 Hours
|
0.020 mmol/L
Standard Deviation 0.033
|
-0.007 mmol/L
Standard Deviation 0.048
|
0.015 mmol/L
Standard Deviation 0.022
|
-0.048 mmol/L
Standard Deviation 0.034
|
-0.087 mmol/L
Standard Deviation 0.030
|
|
Change From Baseline in Serum Corrected Calcium
10 Minutes
|
-0.019 mmol/L
Standard Deviation 0.047
|
-0.008 mmol/L
Standard Deviation 0.081
|
-0.022 mmol/L
Standard Deviation 0.063
|
-0.017 mmol/L
Standard Deviation 0.053
|
-0.030 mmol/L
Standard Deviation 0.049
|
|
Change From Baseline in Serum Corrected Calcium
30 Minutes
|
-0.018 mmol/L
Standard Deviation 0.036
|
-0.008 mmol/L
Standard Deviation 0.079
|
-0.018 mmol/L
Standard Deviation 0.062
|
-0.023 mmol/L
Standard Deviation 0.041
|
-0.042 mmol/L
Standard Deviation 0.037
|
|
Change From Baseline in Serum Corrected Calcium
1 Hour
|
-0.024 mmol/L
Standard Deviation 0.039
|
-0.033 mmol/L
Standard Deviation 0.073
|
-0.023 mmol/L
Standard Deviation 0.056
|
-0.017 mmol/L
Standard Deviation 0.058
|
-0.042 mmol/L
Standard Deviation 0.026
|
|
Change From Baseline in Serum Corrected Calcium
3 Hours
|
-0.001 mmol/L
Standard Deviation 0.035
|
-0.002 mmol/L
Standard Deviation 0.043
|
-0.017 mmol/L
Standard Deviation 0.048
|
-0.025 mmol/L
Standard Deviation 0.066
|
-0.043 mmol/L
Standard Deviation 0.028
|
|
Change From Baseline in Serum Corrected Calcium
6 Hours
|
-0.024 mmol/L
Standard Deviation 0.040
|
-0.048 mmol/L
Standard Deviation 0.056
|
0.008 mmol/L
Standard Deviation 0.066
|
-0.045 mmol/L
Standard Deviation 0.058
|
-0.130 mmol/L
Standard Deviation 0.069
|
|
Change From Baseline in Serum Corrected Calcium
9 Hours
|
-0.010 mmol/L
Standard Deviation 0.041
|
-0.102 mmol/L
Standard Deviation 0.079
|
-0.120 mmol/L
Standard Deviation 0.218
|
-0.126 mmol/L
Standard Deviation 0.043
|
-0.163 mmol/L
Standard Deviation 0.069
|
|
Change From Baseline in Serum Corrected Calcium
12 Hours
|
-0.032 mmol/L
Standard Deviation 0.033
|
-0.035 mmol/L
Standard Deviation 0.048
|
-0.067 mmol/L
Standard Deviation 0.019
|
-0.173 mmol/L
Standard Deviation 0.026
|
-0.228 mmol/L
Standard Deviation 0.042
|
|
Change From Baseline in Serum Corrected Calcium
15 Hours
|
-0.154 mmol/L
Standard Deviation 0.309
|
-0.052 mmol/L
Standard Deviation 0.072
|
-0.107 mmol/L
Standard Deviation 0.039
|
-0.213 mmol/L
Standard Deviation 0.064
|
-0.255 mmol/L
Standard Deviation 0.078
|
|
Change From Baseline in Serum Corrected Calcium
18 Hours
|
-0.067 mmol/L
Standard Deviation 0.076
|
-0.007 mmol/L
Standard Deviation 0.063
|
-0.100 mmol/L
Standard Deviation 0.024
|
-0.187 mmol/L
Standard Deviation 0.058
|
-0.272 mmol/L
Standard Deviation 0.100
|
|
Change From Baseline in Serum Corrected Calcium
21 Hours
|
-0.035 mmol/L
Standard Deviation 0.040
|
0.012 mmol/L
Standard Deviation 0.090
|
-0.090 mmol/L
Standard Deviation 0.023
|
-0.150 mmol/L
Standard Deviation 0.072
|
-0.228 mmol/L
Standard Deviation 0.056
|
|
Change From Baseline in Serum Corrected Calcium
24 Hours
|
-0.015 mmol/L
Standard Deviation 0.026
|
-0.030 mmol/L
Standard Deviation 0.048
|
-0.018 mmol/L
Standard Deviation 0.036
|
-0.156 mmol/L
Standard Deviation 0.031
|
-0.214 mmol/L
Standard Deviation 0.063
|
|
Change From Baseline in Serum Corrected Calcium
27 Hours
|
0.040 mmol/L
Standard Deviation 0.041
|
0.030 mmol/L
Standard Deviation 0.085
|
0.038 mmol/L
Standard Deviation 0.056
|
-0.027 mmol/L
Standard Deviation 0.050
|
-0.115 mmol/L
Standard Deviation 0.055
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dosePopulation: Modified intent-to-treat population with available data at each time point
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Phosphate
10 Minutes
|
-0.033 mmol/L
Standard Deviation 0.035
|
0.007 mmol/L
Standard Deviation 0.094
|
-0.065 mmol/L
Standard Deviation 0.059
|
-0.010 mmol/L
Standard Deviation 0.031
|
0.022 mmol/L
Standard Deviation 0.042
|
|
Change From Baseline in Serum Phosphate
3 Hours
|
0.000 mmol/L
Standard Deviation 0.093
|
-0.013 mmol/L
Standard Deviation 0.140
|
0.005 mmol/L
Standard Deviation 0.096
|
0.110 mmol/L
Standard Deviation 0.104
|
0.060 mmol/L
Standard Deviation 0.083
|
|
Change From Baseline in Serum Phosphate
6 Hours
|
0.008 mmol/L
Standard Deviation 0.153
|
-0.088 mmol/L
Standard Deviation 0.109
|
0.098 mmol/L
Standard Deviation 0.123
|
0.058 mmol/L
Standard Deviation 0.237
|
0.146 mmol/L
Standard Deviation 0.142
|
|
Change From Baseline in Serum Phosphate
30 Minutes
|
-0.041 mmol/L
Standard Deviation 0.067
|
-0.055 mmol/L
Standard Deviation 0.085
|
-0.067 mmol/L
Standard Deviation 0.055
|
-0.017 mmol/L
Standard Deviation 0.042
|
0.012 mmol/L
Standard Deviation 0.056
|
|
Change From Baseline in Serum Phosphate
1 Hour
|
-0.055 mmol/L
Standard Deviation 0.079
|
-0.067 mmol/L
Standard Deviation 0.124
|
-0.058 mmol/L
Standard Deviation 0.039
|
-0.010 mmol/L
Standard Deviation 0.045
|
0.005 mmol/L
Standard Deviation 0.035
|
|
Change From Baseline in Serum Phosphate
9 Hours
|
0.130 mmol/L
Standard Deviation 0.174
|
0.128 mmol/L
Standard Deviation 0.122
|
0.100 mmol/L
Standard Deviation 0.118
|
0.162 mmol/L
Standard Deviation 0.135
|
0.275 mmol/L
Standard Deviation 0.126
|
|
Change From Baseline in Serum Phosphate
12 Hours
|
0.015 mmol/L
Standard Deviation 0.086
|
0.043 mmol/L
Standard Deviation 0.123
|
-0.090 mmol/L
Standard Deviation 0.165
|
-0.018 mmol/L
Standard Deviation 0.164
|
0.028 mmol/L
Standard Deviation 0.143
|
|
Change From Baseline in Serum Phosphate
15 Hours
|
0.228 mmol/L
Standard Deviation 0.251
|
0.258 mmol/L
Standard Deviation 0.132
|
0.188 mmol/L
Standard Deviation 0.180
|
0.220 mmol/L
Standard Deviation 0.139
|
0.355 mmol/L
Standard Deviation 0.141
|
|
Change From Baseline in Serum Phosphate
18 Hours
|
0.381 mmol/L
Standard Deviation 0.150
|
0.357 mmol/L
Standard Deviation 0.120
|
0.307 mmol/L
Standard Deviation 0.120
|
0.375 mmol/L
Standard Deviation 0.113
|
0.538 mmol/L
Standard Deviation 0.100
|
|
Change From Baseline in Serum Phosphate
21 Hours
|
0.278 mmol/L
Standard Deviation 0.164
|
0.315 mmol/L
Standard Deviation 0.132
|
0.312 mmol/L
Standard Deviation 0.065
|
0.296 mmol/L
Standard Deviation 0.129
|
0.518 mmol/L
Standard Deviation 0.120
|
|
Change From Baseline in Serum Phosphate
24 Hours
|
-0.003 mmol/L
Standard Deviation 0.079
|
0.093 mmol/L
Standard Deviation 0.099
|
0.053 mmol/L
Standard Deviation 0.079
|
0.158 mmol/L
Standard Deviation 0.126
|
0.116 mmol/L
Standard Deviation 0.096
|
|
Change From Baseline in Serum Phosphate
27 Hours
|
-0.085 mmol/L
Standard Deviation 0.156
|
-0.003 mmol/L
Standard Deviation 0.124
|
-0.127 mmol/L
Standard Deviation 0.044
|
-0.015 mmol/L
Standard Deviation 0.215
|
0.065 mmol/L
Standard Deviation 0.141
|
|
Change From Baseline in Serum Phosphate
30 Hours
|
0.060 mmol/L
Standard Deviation 0.210
|
0.085 mmol/L
Standard Deviation 0.137
|
0.130 mmol/L
Standard Deviation 0.157
|
0.148 mmol/L
Standard Deviation 0.242
|
0.388 mmol/L
Standard Deviation 0.087
|
|
Change From Baseline in Serum Phosphate
36 Hours
|
0.116 mmol/L
Standard Deviation 0.127
|
0.162 mmol/L
Standard Deviation 0.130
|
0.045 mmol/L
Standard Deviation 0.082
|
0.072 mmol/L
Standard Deviation 0.106
|
0.280 mmol/L
Standard Deviation 0.210
|
|
Change From Baseline in Serum Phosphate
42 Hours
|
0.335 mmol/L
Standard Deviation 0.155
|
0.343 mmol/L
Standard Deviation 0.123
|
0.342 mmol/L
Standard Deviation 0.076
|
0.398 mmol/L
Standard Deviation 0.222
|
0.480 mmol/L
Standard Deviation 0.235
|
|
Change From Baseline in Serum Phosphate
48 Hours
|
0.044 mmol/L
Standard Deviation 0.107
|
0.100 mmol/L
Standard Deviation 0.087
|
0.027 mmol/L
Standard Deviation 0.115
|
0.142 mmol/L
Standard Deviation 0.162
|
0.160 mmol/L
Standard Deviation 0.111
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dosePopulation: Modified intent-to-treat population
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Calcitonin
12 Hours
|
12.14 percent change
Standard Deviation 52.58
|
10.56 percent change
Standard Deviation 25.86
|
-5.07 percent change
Standard Deviation 12.42
|
-10.89 percent change
Standard Deviation 17.56
|
9.71 percent change
Standard Deviation 28.64
|
|
Percent Change From Baseline in Serum Calcitonin
10 Minutes
|
15.92 percent change
Standard Deviation 50.25
|
9.18 percent change
Standard Deviation 14.47
|
-5.07 percent change
Standard Deviation 12.42
|
15.44 percent change
Standard Deviation 29.09
|
51.45 percent change
Standard Deviation 119.74
|
|
Percent Change From Baseline in Serum Calcitonin
30 Minutes
|
17.41 percent change
Standard Deviation 57.12
|
16.72 percent change
Standard Deviation 29.86
|
8.20 percent change
Standard Deviation 37.05
|
24.39 percent change
Standard Deviation 33.50
|
77.35 percent change
Standard Deviation 143.22
|
|
Percent Change From Baseline in Serum Calcitonin
3 Hours
|
11.48 percent change
Standard Deviation 25.51
|
3.33 percent change
Standard Deviation 8.16
|
-0.78 percent change
Standard Deviation 17.80
|
3.12 percent change
Standard Deviation 20.84
|
47.81 percent change
Standard Deviation 109.64
|
|
Percent Change From Baseline in Serum Calcitonin
24 Hours
|
15.51 percent change
Standard Deviation 61.10
|
-1.11 percent change
Standard Deviation 2.72
|
-5.07 percent change
Standard Deviation 12.42
|
-13.45 percent change
Standard Deviation 20.84
|
-4.69 percent change
Standard Deviation 11.48
|
|
Percent Change From Baseline in Serum Calcitonin
48 Hours
|
26.42 percent change
Standard Deviation 74.89
|
5.00 percent change
Standard Deviation 12.25
|
-5.07 percent change
Standard Deviation 12.42
|
0.53 percent change
Standard Deviation 16.81
|
31.58 percent change
Standard Deviation 88.51
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, and 48 hours post-dosePopulation: Modified intent-to-treat population
Outcome measures
| Measure |
Pooled Placebo
n=8 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 Participants
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
12 Hours
|
-14.46 percent change
Standard Deviation 5.49
|
-4.64 percent change
Standard Deviation 12.06
|
-6.12 percent change
Standard Deviation 19.16
|
-18.43 percent change
Standard Deviation 9.44
|
-25.60 percent change
Standard Deviation 7.90
|
|
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
24 Hours
|
-0.61 percent change
Standard Deviation 13.13
|
3.16 percent change
Standard Deviation 16.23
|
4.16 percent change
Standard Deviation 17.23
|
-0.54 percent change
Standard Deviation 15.12
|
-14.51 percent change
Standard Deviation 7.11
|
|
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
48 Hours
|
-4.32 percent change
Standard Deviation 11.22
|
0.09 percent change
Standard Deviation 19.03
|
5.99 percent change
Standard Deviation 18.81
|
0.61 percent change
Standard Deviation 11.49
|
-3.53 percent change
Standard Deviation 16.54
|
SECONDARY outcome
Timeframe: 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
Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for Etelcalcetide
|
43.5 μg/L
Standard Deviation 7.86
|
171 μg/L
Standard Deviation 35.6
|
280 μg/L
Standard Deviation 59.3
|
583 μg/L
Standard Deviation 144
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
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
|
256 hr*μg/L
Standard Deviation 32.5
|
544 hr*μg/L
Standard Deviation 57.7
|
1130 hr*μg/L
Standard Deviation 129
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
|
94.3 hr*μg/L
Standard Deviation 12.5
|
294 hr*μg/L
Standard Deviation 34.1
|
623 hr*μg/L
Standard Deviation 71.5
|
1290 hr*μg/L
Standard Deviation 116
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
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
|
13.2 percentage of AUCINFobs
Standard Deviation 2.57
|
12.6 percentage of AUCINFobs
Standard Deviation 2.43
|
12.0 percentage of AUCINFobs
Standard Deviation 2.79
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) for Etelcalcetide
|
0.0357 1/hr
Standard Deviation 0.00246
|
0.0349 1/hr
Standard Deviation 0.00337
|
0.0378 1/hr
Standard Deviation 0.00486
|
0.0382 1/hr
Standard Deviation 0.00539
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide
|
19.5 hours
Standard Deviation 1.35
|
20.0 hours
Standard Deviation 2.25
|
18.6 hours
Standard Deviation 2.51
|
18.4 hours
Standard Deviation 2.21
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Total Body Clearance (CL) for Etelcalcetide
|
5.38 L/hr
Standard Deviation 0.675
|
6.87 L/hr
Standard Deviation 0.750
|
8.11 L/hr
Standard Deviation 0.928
|
7.83 L/hr
Standard Deviation 0.755
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State for Etelcalcetide
|
113 liters
Standard Deviation 19.6
|
138 liters
Standard Deviation 26.0
|
160 liters
Standard Deviation 21.0
|
152 liters
Standard Deviation 30.0
|
—
|
SECONDARY outcome
Timeframe: Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.Population: Participants who received etelcalcetide
Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 Participants
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 Participants
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 Participants
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|
|
Number of Participants With Antibodies to Etelcalcetide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Etelcalcetide 0.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Etelcalcetide 2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Etelcalcetide 5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Etelcalcetide 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Etelcalcetide Pooled
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pooled Placebo
n=8 participants at risk
Participants received a single dose of placebo administered by intravenous injection.
|
Etelcalcetide 0.5 mg
n=6 participants at risk
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 2 mg
n=6 participants at risk
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 5 mg
n=6 participants at risk
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide 10 mg
n=6 participants at risk
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
|
Etelcalcetide Pooled
n=24 participants at risk
Participants received a single dose of etelcalcetide administered by intravenous injection.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.2%
1/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
12.5%
1/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.5%
1/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
FEELING HOT
|
0.00%
0/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.2%
1/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.2%
1/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
LETHARGY
|
12.5%
1/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.2%
1/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/8 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.2%
1/24 • From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen, Inc
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER