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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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