Trial Details

A Randomized, Double-Blind, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PCO371 in Patients With Hypoparathyroidism

NCT04209179

TERMINATED

DESCRIPTION

This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose Treatment period consists of multiple daily dosing at a fixed dose level. Once patients have completed the Fixed-Dose Treatment period, patients will enter the Dose Titration Treatment period where PCO371 (or placebo), oral calcium and oral active vitamin D can each be titrated according to the patient's albumin-corrected serum calcium level.

CONDITIONS

ELIGIBILITY CRITERIA

• Inclusion Criteria
• : 1. Able and willing to provide written informed consent, to use the device for PRO and electronic diary and to comply with the requirements of the protocol. 2. Adult males or females ≥18 years of age 3. History of hypoparathyroidism for more than 1-year post initial diagnosis 4. PTH level is inappropriately low 5. Dose of thyroid replacement therapy must have been stable for ≥3 months prior to first dose if receiving thyroid replacement therapy 6. Receiving treatment with active vitamin D therapy (calcitriol ≥0.25 μg/day or alfacalcidol ≥0.5 μg/day) 7. Receiving Oral calcium treatment (≥1000 mg/day) 8. No significant changes in the diet from 4 weeks prior to Screening and for the duration of the study. 9. Fasting albumin-corrected serum calcium concentration between 8.0 and 9.0 mg/dL at 2 consecutive visits during the Run-In period, and no more than 25% change in daily doses of oral Ca and active vitamin D between the 2 consecutive visits during the Run-In period. 10. On Day 1, fasting albumin-corrected serum calcium level between 7.5 and 9.0 mg/dL 11. Serum magnesium level ≥ lower limit of normal and ≤ 1.2 x laboratory upper limit of normal 12. Serum 25\[OH\] vitamin D level within the laboratory normal range 13. Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 14. Women of childbearing potential must have a negative highly sensitive urine or serum pregnancy test result 15. For women of childbearing potential: agreement to use a highly effective contraceptive method during the treatment period and for 28 days after the last dose of study drug. Hormonal contraceptive methods must be supplemented by a barrier method (preferably male condom) and agreement to refrain from egg donation during the treatment period and for 28 days after the last dose of study drug. 16. For men: agreement to remain abstinent or use contraceptive measures. Men must refrain from donating sperm during this same period. 17. Ability to comply with the study protocol, in the investigator's judgment. 18. For Canadian sites only: Ferritin, as assessed by the local laboratory at screening, must be ≥ the lower limit of normal (LLN).