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NCT07494045 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by OPKO Health.

Not yet
Registry status
Phase 2
Development phase
40
Enrollment target

NCT07494045 is a Phase 2 study that has not yet begun recruiting, run by OPKO Health. The registered enrollment target is 40 participants.

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The verdict

NCT07494045, a Phase 2 study, has not yet begun recruiting, sponsored by OPKO Health.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target

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.

Interventions

  • DRUG CTAP101

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2026-06
Est. Completion 2028-08
Phase Phase 2

Sponsor

OPKO Health

32 total trials

What the Registry Record Tells You About NCT07494045

The ClinicalTrials.gov registry entry for NCT07494045 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which CTAP101 is the first listed.

NCT07494045 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07494045 about?

NCT07494045 is a clinical study titled "Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants". 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 pharmaco...

What is the current status of trial NCT07494045?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2026-06. Estimated completion is 2028-08.

What interventions are being tested in trial NCT07494045?

The interventions under investigation include: CTAP101 (DRUG).

Who is sponsoring clinical trial NCT07494045?

This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.