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Recruiting NCT07494045

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

Conditions: CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI

Sex: All

Ages: 1 Month – 17 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 40

Sponsor: OPKO Health, Inc.

Location: OPKO Site Kansas City Missouri

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.

Eligibility Criteria

Inclusion Criteria: Each participant must meet the following criteria to be enrolled in Cohort 1 of this study: 1. Be 8 to \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07494045). StuddyBuddy aggregates publicly available trial information.