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

NCT07494045 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • CKD Stage 3
  • CKD Stage 4
  • Secondary Hyperparathyroidism
  • VDI

Interventions

DRUG

CTAP101

Capsules

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-05
Primary Completion
2027-10-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494045 on ClinicalTrials.gov