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Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1

A Phase 2b, Open-label Dose-ranging Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX-305 (Encaleret) in Autosomal Dominant Hypocalcemia (ADH) Type 1

NCT04581629•Calcilytix Therapeutics, Inc., a BridgeBio company

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be able to understand and sign a written informed consent or assent form, which must be obtained prior to initiation of study procedures.
•Postmenopausal women are allowed to participate in this study
•Body mass index (BMI) ≥ 18.5 to \< 39 kilograms (kg)/square meter (m\^2)
•Have an activating mutation of the Calcium-sensing receptor (CASR) gene
•Participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides
•Participants being treated with strong Cytochrome P3A4 (CYP3A4) inhibitors should ideally, if clinically appropriate, discontinue these medications during the screening period
•Participants being treated with magnesium or potassium citrate supplements should discontinue such treatment starting on Day -1 during Period 1 and Period 2 and may be asked to discontinue treatment during Period 3

Exclusion Criteria

•History of treatment with parathyroid hormone (PTH) 1-84 or 1-34 within the previous 3 months
•History of hypocalcemic seizure within the past 3 months
•Blood 25-OH Vitamin D level \< 25 nanograms (ng)/milliliter (mL)
•Participants with hemoglobin (Hgb) \< 13 grams (g)/deciliter (dL) for men and \< 12 g/dL for women
•Estimated glomerular filtration rate (eGFR) \< 25 mL/minute/1.73 m\^2 using Chronic Kidney Disease Epidemiology Collaboration (for participants \<18 years old the Schwartz equation will be calculated)
•12-lead resting electrocardiogram (ECG) with clinically significant abnormalities
•Participants with positive hepatitis B surface antigen (HBsAg), hepatitis A immunoglobulin M (IgM), or human immunodeficiency virus (HIV) viral serology test results at the Screening Visit
•Pregnant or nursing (lactating) women
•History of drug or alcohol dependency within 12 months preceding the Screening Visit
•History of thyroid or parathyroid surgery
+2 more criteria

Locations (1)

National Institutes of Health (NIH) Clinical Center

Bethesda, Maryland, United States

Key Dates

Start Date

September 20, 2020

Primary Completion Date

September 7, 2023

Completion Date

September 7, 2023

Last Updated

November 19, 2024

Enrollment

ACTUAL participants

Conditions

Autosomal Dominant Hypocalcemia (ADH)Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Interventions

Encaleret

DRUG

Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

NCT05680818

Autosomal Dominant Hypocalcemia (ADH)

View study

COMPLETEDPHASE2

Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

NCT00743782

HypoparathyroidismHypocalcemia+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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