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
OPKO Health, Inc.
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.
Eligibility
- Age range
- 0–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Each participant must meet the following criteria to be enrolled in Cohort 1 of this study: 1. Be 8 to \<18 years of age with a body weight of ≥40 kg. 2. Be diagnosed with stage 3 or 4 CKD at least six months prior to the screening visit (Visit 1) and have an eGFR of ≥15 to \<60 mL/min/1.73m2 at screening. 3. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation. 4. Exhibit during the initial or, if necessary, a screening visit after washout: 1. Plasma…
Interventions
- DrugCTAP101
Capsules
Locations (5)
- OPKO SiteKansas City, Missouri
- OPKO SiteColumbus, Ohio
- OPKO SitePhiladelphia, Pennsylvania
- OPKO SiteGreenville, South Carolina
- OPKO SiteMadison, Wisconsin