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RECRUITING
NCT07080385
PHASE2/PHASE3

Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 2/3, Multicenter, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Key Details

Gender

All

Age Range

0 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-01-30

Completion Date

2030-12

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

Encaleret

Oral tablets, age-appropriate pediatric formulation (currently under development).

Locations (5)

Yale University

New Haven, Connecticut, United States

Nemours Children's Health

Jacksonville, Florida, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Royal London Hospital

London, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom