Trials / Recruiting
RecruitingNCT07080385
Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
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)
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company · Industry
- Sex
- All
- Age
- 0 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Encaleret | Oral tablets, age-appropriate pediatric formulation (currently under development). |
Timeline
- Start date
- 2026-01-30
- Primary completion
- 2028-12-01
- Completion
- 2030-12-01
- First posted
- 2025-07-23
- Last updated
- 2026-03-11
Locations
5 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07080385. Inclusion in this directory is not an endorsement.