Actively Recruiting
Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Led by Calcilytix Therapeutics, Inc., a BridgeBio company · Updated on 2026-04-22
28
Participants Needed
6
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall objective of this study is to evaluate the pharmacokinetics (PK), efficacy, and safety of encaleret in pediatric participants from birth to 17 years of age with ADH1.
CONDITIONS
Official Title
Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent or have parent/legal guardian consent and assent as appropriate
- Have a pathogenic or likely pathogenic variant or uncertain variant of the calcium-sensing receptor gene related to hypoparathyroidism
- Show at least one symptom or sign of hypoparathyroidism at screening or have a history of such symptoms
- Be on treatment for ADH1 for at least 6 months before screening for cohorts 1 to 3 or at least 3 months for cohort 4
You will not qualify if you...
- History of thyroid or parathyroid surgery
- History of kidney transplant
- History of certain cancers or bone diseases within 5 years before screening
- Recent use of investigational drugs within 30 days or 5 half-lives before Day 1
- Recent treatment with strong P-glycoprotein inhibitors or cardiac glycosides
- Being breastfed by a mother treated with cardiac glycosides
- Any condition that could affect safety, treatment compliance, or ability to complete the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Nemours Children's Health
Jacksonville, Florida, United States, 32207
Actively Recruiting
4
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
6
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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