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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
OPKO Health, Inc.
Study ID
NCT07494045
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • CKD Stage 3
  • CKD Stage 4
  • Secondary Hyperparathyroidism
  • VDI

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • CTAP101 — DRUG
    Capsules

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Group A
    30 mcg CTAP101 Capsules
  • Experimental: Cohort 1 - Group B
    30 mcg or 60 mcg CTAP101 Capsules

Primary Outcome Measure

Apparent clearance (CL/F) [ Time Frame: Up to 14 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
OPKO SiteKansas CityMissouri64108
Clinical Project Manager
[email protected]
305-575-4000
OPKO SiteColumbusOhio43205
Clinical Project Manager
[email protected]
305-575-4000
OPKO SitePhiladelphiaPennsylvania19104
Clinical Project Manager
[email protected]
305-575-4000
OPKO SiteGreenvilleSouth Carolina29615
Clinical Project Manager
[email protected]
305-575-4000
OPKO SiteMadisonWisconsin53562
Clinical Project Manager
[email protected]
305-575-4000

Find similar trials in Kansas City, MO

By research site
OPKO Site· Kansas City, MOOPKO Site· Columbus, OHOPKO Site· Philadelphia, PAOPKO Site· Greenville, SCOPKO Site· Madison, WI

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