Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
Public ClinicalTrials.gov record NCT07494045. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants <18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07494045
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 4, 2026
- Primary completion
- Sep 30, 2027
- Completion
- Jul 31, 2028
- Last update posted
- Aug 19, 2026
2026 – 2028
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| OPKO Site | Kansas City | Missouri | 64108 | Not yet recruiting |
| OPKO Site | Columbus | Ohio | 43205 | Not yet recruiting |
| OPKO Site | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| OPKO Site | Greenville | South Carolina | 29615 | Recruiting |
| OPKO Site | Madison | Wisconsin | 53562 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07494045, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07494045 live on ClinicalTrials.gov.