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A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations

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ClinicalTrials.gov Identifier: NCT02204579
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autosomal Dominant Hypocalcemia (ADH)
Intervention Drug: NPSP795
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NPSP795
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 7
Participants Started in Pre-Amendment 2 [1]
Participants Started in Post-Amendment 5 [2]
Treated 5
Completed 5
Not Completed 2
Reason Not Completed
Screen failures             2
[1]
Two participants completed treatment in pre-amendment and were re-enrolled in post-amendment.
[2]
Two participants from pre-amendment were re-enrolled with different identification numbers.
Arm/Group Title NPSP795
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
39.8  (15.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description [Not Specified]
Time Frame From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
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Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).
Arm/Group Title NPSP795
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[Not Specified]
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Participants with TEAEs 3
Participants with TESAEs 1
2.Primary Outcome
Title Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities
Hide Description [Not Specified]
Time Frame From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
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Hide Analysis Population Description
Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).
Arm/Group Title NPSP795
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
0
3.Primary Outcome
Title Number of Participants With Potentially Clinically Important Laboratory Abnormalities
Hide Description [Not Specified]
Time Frame From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).
Arm/Group Title NPSP795
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
1
4.Primary Outcome
Title Number of Participants With Clinically Significant Abnormalities Related to Physical Examination
Hide Description [Not Specified]
Time Frame From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).
Arm/Group Title NPSP795
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
1
5.Primary Outcome
Title Change From Baseline in Ionised Calcium at Specified Timepoint
Hide Description [Not Specified]
Time Frame Baseline (Predose), 4 Hours and 8 Hours Postdose
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Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: millimole/liter (mmol/L)
Baseline (n=5,5,5,3,2) 0.972  (0.058) 0.950  (0.054) 0.986  (0.045) 0.933  (0.055) 1.025  (0.078)
Change at 4 Hours Post dose (n=5,5,5,3,2) -0.016  (0.027) 0.010  (0.026) -0.014  (0.023) -0.030  (0.046) -0.015  (0.035)
Change at 8 Hours Post dose (n=5,5,5,3,2) NA [1]   (NA) -0.034  (0.044) -0.040  (0.060) -0.033  (0.046) -0.060  (0.028)
[1]
Data was calculated for 5 mg/10 minutes infusion until hour 4 only.
6.Primary Outcome
Title Change From Baseline in Serum Calcium at 12 Hours Postdose
Hide Description [Not Specified]
Time Frame Baseline (Predose) to 12 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: millimole/liter (mmol/L)
Baseline (n=5,5,5,3,2) 1.914  (0.157) 1.790  (0.125) 1.852  (0.132) 1.677  (0.135) 1.980  (0.184)
Change at 12 Hours Postdose (n=5,5,5,3,2) -0.114  (0.141) -0.042  (0.054) -0.106  (0.079) -0.040  (0.053) -0.270  (0.057)
7.Primary Outcome
Title Change From Baseline in Urinary Calcium at 12 Hours Postdose
Hide Description [Not Specified]
Time Frame Baseline (Predose) to 12 Hours Postdose
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Hide Analysis Population Description
PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: millimole/liter (mmol/L)
Baseline (n=5,5,5,3,2) 3.302  (2.283) 3.912  (3.299) 2.936  (1.750) 2.537  (1.968) 2.065  (1.916)
Change at 12 Hours Postdose (n=5,5,5,3,2) -0.590  (0.861) -2.162  (2.027) -1.188  (1.634) -1.190  (1.460) -0.755  (1.082)
8.Primary Outcome
Title Change From Baseline in Serum Parathyroid Hormone (PTH) at Specified Time Point
Hide Description [Not Specified]
Time Frame Baseline (Predose), 5.5 Hours, 8 Hours Postdose
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Hide Analysis Population Description
Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: nanogram/liter (ng/L)
Baseline (n=5,5,5,3,2) 7.32  (2.93) 9.14  (3.29) 9.58  (5.32) 12.80  (8.68) 7.40  (3.54)
Change at 5.5 Hours Postdose (n=5,5,5,3,2) NA [1]   (NA) 0.84  (0.86) 1.92  (1.53) 0.13  (1.50) 1.75  (0.64)
Change at 8 Hours Postdose (n=5,5,5,3,2) 0.60  (1.56) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Data for 10 minutes infusion was not calculated at 5.5-hours.
[2]
Data for 3.5-hours infusions was calculated until hour 5.5 only.
9.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795
Hide Description [Not Specified]
Time Frame Baseline (Predose), and 15, 30 Minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose
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Hide Analysis Population Description
Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 3 2
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per millilitre (ng·h/mL)
309.512  (122.601) 795.766  (294.345) 1561.746  (546.479) 1657.057  (650.156) 2251.818  (568.782)
10.Secondary Outcome
Title Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795
Hide Description [Not Specified]
Time Frame Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 3 2
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter(ng·h/mL)
2.672  (1.775) 5.572  (2.724) 5.437  (2.587) 7.648  (3.607) 4.521  (2.991)
11.Secondary Outcome
Title Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma
Hide Description [Not Specified]
Time Frame Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Post amendment PK analysis population included all randomized participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least one day of infusion.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 3 2
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
301.900  (120.664) 745.335  (254.205) 1467.102  (475.343) 1515.086  (548.056) 2141.500  (475.706)
12.Secondary Outcome
Title Elimination Half-life (t1/2) of NPSP795 in Plasma
Hide Description [Not Specified]
Time Frame Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 3 2
Mean (Standard Deviation)
Unit of Measure: hour
3.013  (0.612) 3.913  (0.222) 4.213  (0.449) 3.839  (0.294) 4.000  (0.000)
13.Secondary Outcome
Title Change From Baseline in Fractional Excretion of Calcium (FECa) at 12 Hours Postdose
Hide Description [Not Specified]
Time Frame Baseline (Predose) to 12 Hours Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here n=number of participants analysed for specified category at the specified time points in each arm respectively.
Arm/Group Title NPSP795 on Day 1 (5 mg/10 Minutes) NPSP795 on Day 2 (15 mg/3.5 Hours) NPSP795 on Day 3 (30 mg/3.5 Hours) NPSP795 on Day 4 (30 mg/3.5 Hours) NPSP795 on Day 4 (50 mg/3.5 Hours)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: Fraction of excretion
FECa: Baseline (n=5,5,5,3,2) 0.030  (0.023) 0.031  (0.017) 0.027  (0.014) 0.030  (0.011) 0.026  (0.032)
FECa: Change at 12 Hours Postdose (n=5,5,5,3,2) 0.002  (0.005) 0.002  (0.012) 0.001  (0.011) -0.009  (0.018) 0.002  (0.007)
Time Frame From the sign of informed consent form (Day -93) up to safety follow-up assessment (upto Day 17 after discharge)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NPSP795
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
NPSP795
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NPSP795
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Hepatobiliary disorders   
Cholelithiasis * 1  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NPSP795
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Hepatobiliary disorders   
Cholelithiasis * 1  1/5 (20.00%)  1
Immune system disorders   
Hypersensitivity reaction * 1  1/5 (20.00%)  2
Reproductive system and breast disorders   
Nipple pain * 1  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
[Not Specified]
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: 1 866-842-5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02204579     History of Changes
Other Study ID Numbers: CAL-C13-001
First Submitted: July 28, 2014
First Posted: July 30, 2014
Results First Submitted: October 27, 2016
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016