An Open-label, Single-dose Study to Determine the Pharmacokinetic/Pharmacodynamic Profile of Parathyroid Hormone (rDNA) Administered Subcutaneously at a Dose of50 µg in Subjects with Hypoparathyroidism Who Are 12 to LessThan 18 Years of Age

PS Pharmaceuticals, Inc.0 个研究点目标入组 10 人开始时间: 2015年10月26日最近更新: 2020年7月27日

试验速览

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•Parent/guardian or emancipated minor willing and able to provide informed consent, and minor (non-emancipated) subject willing and able to provide informed assent prior to any study-related procedures
•Subjects aged 12 to less than 18 years inclusive at the final visit (Study Day 3)
•Completed the screening process within 90 days prior to dosing
•Body weight > 30 kg
•Hemoglobin level = 11 g/dL
•History of hypoparathyroidism for at least 6 months post-diagnosis, inclusive of historical biochemical evidence of hypocalcemia with concomitant serum intact parathyroid hormone (PTH) concentrations below the lower limit of the laboratory normal range
•Subjects who are treated with both oral calcium and active vitamin D must require oral calcium treatment over and above normal dietary calcium intake = 500 mg/day and active vitamin D therapy at a dose of = 0.5 µg/day for calcitriol or = 1 µg/day for alphacalcidol.
•If a subject does not take oral calcium, the active vitamin D dosage must be
•= 1 µg/day for calcitriol or = 2 µg/day for alphacalcidol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Participation in any other investigational drug study in which receipt of investigational drug occurred within 6 months prior to study entry.
•Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s)
•Known history of hypoparathyroidism resulting from an activating mutation in the calcium-sensing receptor (CaSR) gene or impaired responsiveness to PTH (pseudohypoparathyroidism)
•Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism such as active hyperthyroidism; Paget's disease; poorly controlled insulin-dependent diabetes mellitus; severe and chronic cardiac, liver or renal disease; Cushing's syndrome; neuromuscular disease such as rheumatoid arthritis; myeloma; pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy, bone metastases or history of skeletal malignancies; primary or secondary hyperparathyroidism; a history of parathyroid carcinoma; hypopituitarism; acromegaly; or multiple endocrine neoplasia types I and II
•Subjects who required parenteral calcium infusions (eg, calcium gluconate) to maintain calcium homeostasis within 3 months prior to enrollment

发起方

PS Pharmaceuticals, Inc.