Status:
COMPLETED
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
Lead Sponsor:
Shire
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Autosomal Dominant Hypocalcemia (ADH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor antagonist) on activating mutations of the Calcium-sensing receptor in patients with Autosomal Dominant Hypo...
Eligibility Criteria
Inclusion
- Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit
- At least 18 years of age
- Body mass index (BMI) ≥ 18.5 to \< 39 kg/m2
Exclusion
- Diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of NPSP795
- History of treatment with PTH 1-84 or 1-34 within the previous 6 months
- History of hypocalcemia requiring frequent IV calcium infusions
- History of hypocalcemic seizure within the past 3 months
- Blood 25-hydroxy vitamin D level \< 25 ng/mL. If subjects have a blood 25-hydroxy vitamin D level \< 25 ng/mL at the outpatient screening visit, they will be prescribed vitamin D replacement. Once the 25-hydroxy vitamin D level is \> 25 ng/mL, the subject will be eligible to continue on to the treatment phase of the study
- Estimated glomerular filtration rate (GFR) \< 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function
- 12 lead resting electrocardiogram (ECG) with clinically significant abnormalities
- Concomitant medications with the potential to interfere with NPSP795 metabolism
- History of thyroid or parathyroid surgery
Key Trial Info
Start Date :
July 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02204579
Start Date
July 18 2014
End Date
May 4 2015
Last Update
August 9 2021
Active Locations (1)
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1
National Institute of Health (NIH)
Bethesda, Maryland, United States, 20892-1103