encaleret
DrugOral tablets, age-appropriate pediatric formulation (currently under development).
NCT Number: NCT07080385
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.
Interested in participating?
Request Info0 year–17 year
All sexes
Interventional
Phase 2 / Phase 3
Royal London Hospital, London, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply.
Oral tablets, age-appropriate pediatric formulation (currently under development).
Time frame: 5 days
Time frame: 5 days
Time frame: Week 25
Time frame: Baseline up to Day 5
Time frame: Baseline up to Day 5
Time frame: Baseline up to Day 5
Time frame: Baseline up to Day 5
Time frame: Baseline up to Day 5
Time frame: Baseline up to Day 5
Time frame: Baseline up to Day 5
Time frame: Week 25 (post-dose)
Time frame: Week 25
Time frame: Week 25
Time frame: Week 25
Time frame: Baseline up to Week 25
Time frame: 25 weeks
Time frame: 25 weeks
Time frame: 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Time frame: Baseline up to 145 weeks
Contact information is provided by the study sponsor or research team.
Calcilytix Therapeutics, Inc., a BridgeBio company
Industry
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)
Acronym: CALIBRATE-PEDS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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