Yükleniyor... / Loading...
This study evaluates the effect of the drug NPSP795 on parathyroid hormone (PTH) levels and blood calcium in patients with Autosomal Dominant Hypocalcemia (an inherited condition of low blood calcium) caused by an activating mutation in the CaSR (calcium-sensing receptor) gene. It included patients over 18 with a confirmed CaSR mutation. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 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 Criteria: * 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