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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: Clinical Trial Phase 2 study, sponsored by OPKO Health.
NCT07494045 is a Phase 2 study that has not yet begun recruiting, run by OPKO Health. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the CL/F of CTAP101 Capsules during and after repeated dosing
Interventions
- DRUG CTAP101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What is known before NCT07494045 opens enrollment
NCT07494045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which CTAP101 is the first listed.
NCT07494045 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07494045's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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