Clinical Trial

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are: 1. To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules 2. To investigate the safety and tolerability of CTAP101 Capsules Participants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-20.
Trial Details
NCT Number NCT07494045
Lead Sponsor OPKO Health, Inc.
Conditions CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI
Enrollment 40 participants
Start Date 2026-06
Primary Completion 2027-10 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-30