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Trial record 79 of 108 for:    CALCIUM CATION

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01134549
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Nucleus Network Ltd
Information provided by (Responsible Party):
KAI Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hyperparathyroidism, Secondary
Interventions Drug: Etelcalcetide
Drug: Placebo
Enrollment 32
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.
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description Participants received a single dose of placebo administered by intravenous injection. Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Period Title: Overall Study
Started 8 6 6 6 6
Completed 8 6 6 6 6
Not Completed 0 0 0 0 0
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg Total
Hide Arm/Group Description Participants received a single dose of placebo administered by intravenous injection. Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. Total of all reporting groups
Overall Number of Baseline Participants 8 6 6 6 6 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants 32 participants
22.4  (3.5) 27.8  (8.9) 26.8  (4.9) 24.2  (4.4) 26.0  (6.2) 25.3  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants 32 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
32
 100.0%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants 32 participants
White
6
  75.0%
4
  66.7%
6
 100.0%
3
  50.0%
4
  66.7%
23
  71.9%
Asian
2
  25.0%
2
  33.3%
0
   0.0%
2
  33.3%
2
  33.3%
8
  25.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   3.1%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants 32 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
   3.1%
Not Hispanic or Latino
8
 100.0%
6
 100.0%
5
  83.3%
6
 100.0%
6
 100.0%
31
  96.9%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame From the first dose of study drug through 7 days.
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication.
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Measure Type: Number
Unit of Measure: participants
Any adverse event 2 0 1 2 2
Serious adverse events 0 0 0 0 0
Withdrawals due to adverse events 0 0 0 0 0
Treatment-related adverse events 0 0 1 1 1
Deaths 0 0 0 0 0
2.Secondary Outcome
Title Percent Change From Baseline in Serum Parathyroid Hormone
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percent change
10 Minutes 4.57  (15.42) -20.58  (4.25) -45.09  (9.31) -59.38  (8.89) -63.31  (8.11)
30 Minutes -3.52  (16.29) -21.74  (9.55) -55.42  (4.31) -69.00  (7.02) -72.56  (6.33)
1 Hour 1.11  (12.85) -18.71  (11.68) -47.16  (7.94) -67.72  (10.84) -73.29  (6.97)
3 Hours 1.76  (26.67) -5.95  (7.62) -39.87  (10.87) -62.56  (13.30) -69.70  (7.62)
6 Hours -2.57  (30.28) 7.01  (10.64) -41.56  (12.03) -60.87  (13.41) -66.68  (10.41)
9 Hours 19.87  (25.16) 46.50  (27.97) 12.54  (40.52) -40.79  (15.91) -54.43  (12.97)
12 Hours 30.49  (28.14) 8.07  (17.54) 5.04  (27.93) -24.05  (13.94) -40.28  (19.35)
15 Hours 31.97  (25.22) 4.17  (19.38) 20.06  (39.27) -2.33  (21.12) -24.31  (17.06)
18 Hours 27.21  (15.21) -6.22  (11.89) 25.91  (28.39) 2.19  (20.72) -15.78  (13.66)
21 Hours 9.65  (16.08) -0.67  (20.04) 22.04  (16.74) -2.10  (25.36) -4.02  (19.11)
24 Hours -9.50  (16.20) -1.72  (22.40) -14.65  (13.43) -19.25  (17.66) -18.34  (15.17)
27 Hours -21.56  (11.39) -27.97  (10.32) -34.76  (13.58) -49.48  (12.23) -37.15  (18.99)
30 Hours 10.58  (15.51) -8.19  (14.90) 1.21  (21.70) -11.15  (23.59) -25.32  (12.63)
36 Hours 25.24  (20.51) 18.19  (25.35) 20.63  (34.27) 17.61  (37.53) 1.08  (27.77)
42 Hours 6.15  (26.47) 3.28  (11.15) 1.49  (23.88) -19.21  (20.33) -29.37  (21.78)
48 Hours -13.90  (15.92) -10.39  (12.66) -4.86  (26.04) -24.02  (15.00) -10.84  (20.60)
3.Secondary Outcome
Title Percent Change From Baseline in Plasma Ionized Calcium
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percent change
10 Minutes -1.48  (3.55) 0.98  (2.79) -3.94  (2.33) -5.30  (2.13) -2.47  (2.79)
30 Minutes -1.27  (3.67) -0.51  (3.54) -2.46  (3.20) -6.87  (2.06) 1.18  (2.92)
1 Hour -1.15  (4.62) 1.15  (3.08) -4.50  (2.65) -4.12  (2.08) -3.27  (1.52)
3 Hours -1.72  (4.85) 0.73  (1.40) -5.86  (2.52) -6.65  (2.31) -1.83  (4.07)
6 Hours -1.79  (3.32) -1.36  (2.66) -4.88  (2.58) -9.95  (1.91) -2.84  (2.67)
9 Hours -4.68  (3.76) -3.39  (5.00) -9.51  (5.40) -16.45  (2.55) -9.54  (5.32)
12 Hours -7.14  (3.93) -2.83  (3.22) -9.54  (2.17) -15.27  (1.49) -14.92  (5.47)
15 Hours -3.71  (4.25) -2.53  (2.98) -10.41  (1.32) -15.38  (3.05) -11.74  (4.08)
18 Hours -3.38  (4.24) -1.62  (5.07) -9.00  (1.18) -14.33  (2.31) -12.34  (3.27)
21 Hours -1.11  (3.56) 3.90  (3.60) -6.38  (1.74) -13.97  (2.48) -11.77  (1.85)
24 Hours -0.70  (4.64) 3.77  (1.93) -2.45  (1.95) -11.83  (4.46) -11.59  (4.49)
27 Hours -1.78  (4.12) 2.62  (3.73) -6.26  (2.74) -7.71  (2.28) -7.89  (1.46)
30 Hours 0.17  (4.11) 2.51  (3.84) -5.82  (2.06) -9.65  (2.73) -11.78  (5.66)
36 Hours -5.02  (5.40) -3.28  (5.39) -7.68  (3.35) -13.69  (4.43) -9.45  (3.11)
42 Hours -1.38  (3.56) 0.55  (3.44) 0.14  (1.32) -5.92  (3.30) -3.40  (3.07)
48 Hours 2.12  (4.24) 2.17  (2.91) -0.42  (1.83) -6.22  (3.17) -0.39  (2.85)
4.Secondary Outcome
Title Change From Baseline in Serum Total Calcium
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population with available data at each time point
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mmol/L
10 Minutes Number Analyzed 7 participants 6 participants 6 participants 6 participants 6 participants
-0.019  (0.047) -0.008  (0.081) -0.022  (0.063) -0.017  (0.053) -0.030  (0.049)
30 Minutes Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.018  (0.036) -0.008  (0.079) -0.018  (0.062) -0.023  (0.041) -0.042  (0.037)
1 Hour Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.024  (0.039) -0.033  (0.073) -0.023  (0.056) -0.017  (0.058) -0.042  (0.026)
3 Hours Number Analyzed 7 participants 6 participants 6 participants 6 participants 6 participants
-0.001  (0.035) -0.018  (0.074) -0.017  (0.048) -0.025  (0.066) -0.050  (0.032)
6 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 5 participants
-0.024  (0.040) -0.065  (0.090) 0.008  (0.066) -0.045  (0.058) -0.138  (0.061)
9 Hours Number Analyzed 8 participants 5 participants 6 participants 5 participants 6 participants
-0.010  (0.041) -0.122  (0.117) -0.120  (0.218) -0.126  (0.043) -0.170  (0.065)
12 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.055  (0.038) -0.058  (0.080) -0.067  (0.024) -0.203  (0.041) -0.285  (0.079)
15 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.176  (0.324) -0.075  (0.105) -0.107  (0.039) -0.243  (0.064) -0.312  (0.056)
18 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.090  (0.074) -0.030  (0.077) -0.100  (0.027) -0.217  (0.045) -0.328  (0.075)
21 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 6 participants
-0.058  (0.038) -0.012  (0.113) -0.090  (0.041) -0.174  (0.040) -0.285  (0.039)
24 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 5 participants
-0.025  (0.030) -0.040  (0.076) -0.038  (0.061) -0.200  (0.036) -0.270  (0.072)
27 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.030  (0.037) 0.020  (0.106) 0.018  (0.080) -0.070  (0.057) -0.165  (0.058)
30 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 5 participants
-0.003  (0.036) 0.025  (0.102) -0.013  (0.063) -0.165  (0.071) -0.182  (0.057)
36 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.035  (0.035) -0.002  (0.074) -0.058  (0.084) -0.143  (0.077) -0.210  (0.040)
42 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 6 participants
-0.009  (0.055) -0.033  (0.085) 0.002  (0.029) -0.100  (0.021) -0.120  (0.045)
48 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.013  (0.042) -0.010  (0.093) 0.018  (0.038) -0.085  (0.036) -0.107  (0.047)
5.Secondary Outcome
Title Change From Baseline in Serum Corrected Calcium
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population with available data at each time point
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mmol/L
10 Minutes Number Analyzed 7 participants 6 participants 6 participants 6 participants 6 participants
-0.019  (0.047) -0.008  (0.081) -0.022  (0.063) -0.017  (0.053) -0.030  (0.049)
30 Minutes Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.018  (0.036) -0.008  (0.079) -0.018  (0.062) -0.023  (0.041) -0.042  (0.037)
1 Hour Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.024  (0.039) -0.033  (0.073) -0.023  (0.056) -0.017  (0.058) -0.042  (0.026)
3 Hours Number Analyzed 7 participants 6 participants 6 participants 6 participants 6 participants
-0.001  (0.035) -0.002  (0.043) -0.017  (0.048) -0.025  (0.066) -0.043  (0.028)
6 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 5 participants
-0.024  (0.040) -0.048  (0.056) 0.008  (0.066) -0.045  (0.058) -0.130  (0.069)
9 Hours Number Analyzed 8 participants 5 participants 6 participants 5 participants 6 participants
-0.010  (0.041) -0.102  (0.079) -0.120  (0.218) -0.126  (0.043) -0.163  (0.069)
12 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.032  (0.033) -0.035  (0.048) -0.067  (0.019) -0.173  (0.026) -0.228  (0.042)
15 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.154  (0.309) -0.052  (0.072) -0.107  (0.039) -0.213  (0.064) -0.255  (0.078)
18 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.067  (0.076) -0.007  (0.063) -0.100  (0.024) -0.187  (0.058) -0.272  (0.100)
21 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 6 participants
-0.035  (0.040) 0.012  (0.090) -0.090  (0.023) -0.150  (0.072) -0.228  (0.056)
24 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 5 participants
-0.015  (0.026) -0.030  (0.048) -0.018  (0.036) -0.156  (0.031) -0.214  (0.063)
27 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.040  (0.041) 0.030  (0.085) 0.038  (0.056) -0.027  (0.050) -0.115  (0.055)
30 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 5 participants
0.008  (0.035) 0.035  (0.078) 0.007  (0.046) -0.125  (0.067) -0.138  (0.064)
36 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.025  (0.037) 0.008  (0.046) -0.038  (0.081) -0.103  (0.068) -0.157  (0.051)
42 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 6 participants
0.001  (0.060) -0.023  (0.061) 0.022  (0.026) -0.056  (0.021) -0.067  (0.036)
48 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.020  (0.033) -0.007  (0.048) 0.015  (0.022) -0.048  (0.034) -0.087  (0.030)
6.Secondary Outcome
Title Change From Baseline in Serum Phosphate
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population with available data at each time point
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mmol/L
10 Minutes Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.033  (0.035) 0.007  (0.094) -0.065  (0.059) -0.010  (0.031) 0.022  (0.042)
30 Minutes Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.041  (0.067) -0.055  (0.085) -0.067  (0.055) -0.017  (0.042) 0.012  (0.056)
1 Hour Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.055  (0.079) -0.067  (0.124) -0.058  (0.039) -0.010  (0.045) 0.005  (0.035)
3 Hours Number Analyzed 7 participants 6 participants 6 participants 6 participants 6 participants
0.000  (0.093) -0.013  (0.140) 0.005  (0.096) 0.110  (0.104) 0.060  (0.083)
6 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 5 participants
0.008  (0.153) -0.088  (0.109) 0.098  (0.123) 0.058  (0.237) 0.146  (0.142)
9 Hours Number Analyzed 8 participants 5 participants 6 participants 5 participants 6 participants
0.130  (0.174) 0.128  (0.122) 0.100  (0.118) 0.162  (0.135) 0.275  (0.126)
12 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.015  (0.086) 0.043  (0.123) -0.090  (0.165) -0.018  (0.164) 0.028  (0.143)
15 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.228  (0.251) 0.258  (0.132) 0.188  (0.180) 0.220  (0.139) 0.355  (0.141)
18 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.381  (0.150) 0.357  (0.120) 0.307  (0.120) 0.375  (0.113) 0.538  (0.100)
21 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 6 participants
0.278  (0.164) 0.315  (0.132) 0.312  (0.065) 0.296  (0.129) 0.518  (0.120)
24 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 5 participants
-0.003  (0.079) 0.093  (0.099) 0.053  (0.079) 0.158  (0.126) 0.116  (0.096)
27 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
-0.085  (0.156) -0.003  (0.124) -0.127  (0.044) -0.015  (0.215) 0.065  (0.141)
30 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 5 participants
0.060  (0.210) 0.085  (0.137) 0.130  (0.157) 0.148  (0.242) 0.388  (0.087)
36 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.116  (0.127) 0.162  (0.130) 0.045  (0.082) 0.072  (0.106) 0.280  (0.210)
42 Hours Number Analyzed 8 participants 6 participants 6 participants 5 participants 6 participants
0.335  (0.155) 0.343  (0.123) 0.342  (0.076) 0.398  (0.222) 0.480  (0.235)
48 Hours Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants
0.044  (0.107) 0.100  (0.087) 0.027  (0.115) 0.142  (0.162) 0.160  (0.111)
7.Secondary Outcome
Title Percent Change From Baseline in Serum Calcitonin
Hide Description [Not Specified]
Time Frame Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percent change
10 Minutes 15.92  (50.25) 9.18  (14.47) -5.07  (12.42) 15.44  (29.09) 51.45  (119.74)
30 Minutes 17.41  (57.12) 16.72  (29.86) 8.20  (37.05) 24.39  (33.50) 77.35  (143.22)
3 Hours 11.48  (25.51) 3.33  (8.16) -0.78  (17.80) 3.12  (20.84) 47.81  (109.64)
12 Hours 12.14  (52.58) 10.56  (25.86) -5.07  (12.42) -10.89  (17.56) 9.71  (28.64)
24 Hours 15.51  (61.10) -1.11  (2.72) -5.07  (12.42) -13.45  (20.84) -4.69  (11.48)
48 Hours 26.42  (74.89) 5.00  (12.25) -5.07  (12.42) 0.53  (16.81) 31.58  (88.51)
8.Secondary Outcome
Title Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
Hide Description [Not Specified]
Time Frame Baseline and 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of placebo administered by intravenous injection.
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 8 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percent change
12 Hours -14.46  (5.49) -4.64  (12.06) -6.12  (19.16) -18.43  (9.44) -25.60  (7.90)
24 Hours -0.61  (13.13) 3.16  (16.23) 4.16  (17.23) -0.54  (15.12) -14.51  (7.11)
48 Hours -4.32  (11.22) 0.09  (19.03) 5.99  (18.81) 0.61  (11.49) -3.53  (16.54)
9.Secondary Outcome
Title Maximum Observed Concentration (Cmax) for Etelcalcetide
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: μg/L
43.5  (7.86) 171  (35.6) 280  (59.3) 583  (144)
10.Secondary Outcome
Title Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr*μg/L
81.1  (11.7) 256  (32.5) 544  (57.7) 1130  (129)
11.Secondary Outcome
Title Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr*μg/L
94.3  (12.5) 294  (34.1) 623  (71.5) 1290  (116)
12.Secondary Outcome
Title Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percentage of AUCINFobs
14.0  (1.33) 13.2  (2.57) 12.6  (2.43) 12.0  (2.79)
13.Secondary Outcome
Title Terminal Elimination Rate Constant (λz) for Etelcalcetide
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.0357  (0.00246) 0.0349  (0.00337) 0.0378  (0.00486) 0.0382  (0.00539)
14.Secondary Outcome
Title Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
19.5  (1.35) 20.0  (2.25) 18.6  (2.51) 18.4  (2.21)
15.Secondary Outcome
Title Total Body Clearance (CL) for Etelcalcetide
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: L/hr
5.38  (0.675) 6.87  (0.750) 8.11  (0.928) 7.83  (0.755)
16.Secondary Outcome
Title Volume of Distribution at Steady State for Etelcalcetide
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: liters
113  (19.6) 138  (26.0) 160  (21.0) 152  (30.0)
17.Secondary Outcome
Title Number of Participants With Antibodies to Etelcalcetide
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received etelcalcetide
Arm/Group Title Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg
Hide Arm/Group Description:
Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame From the first dose of study drug through 7 days
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide Pooled
Hide Arm/Group Description Participants received a single dose of placebo administered by intravenous injection. Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. Participants received a single dose of etelcalcetide administered by intravenous injection.
All-Cause Mortality
Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pooled Placebo Etelcalcetide 0.5 mg Etelcalcetide 2 mg Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   0/6 (0.00%)   1/6 (16.67%)   2/6 (33.33%)   2/6 (33.33%)   5/24 (20.83%) 
Gastrointestinal disorders             
ABDOMINAL DISCOMFORT  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/24 (4.17%) 
ABDOMINAL PAIN  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/24 (0.00%) 
DIARRHOEA  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/24 (0.00%) 
General disorders             
FEELING HOT  1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders             
BACK PAIN  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/24 (4.17%) 
Nervous system disorders             
LETHARGY  1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/24 (0.00%) 
PARAESTHESIA  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders             
EPISTAXIS  1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen, Inc
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01134549     History of Changes
Other Study ID Numbers: KAI-4169-001
20130107 ( Other Identifier: Amgen, Inc )
First Submitted: May 28, 2010
First Posted: June 2, 2010
Results First Submitted: February 28, 2017
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017