Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
← catalyst calendarNCT07494045 · readout ≤ 438 d
Sponsored by OPKO Health, Inc. (industry) · OPK — their whole pipeline →.
Phase
Phase 2
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
40estimated
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Jun 2026 | estimated | When the study began enrolling |
| Primary completion | Oct 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- CKD Stage 3
- CKD Stage 4
- Secondary Hyperparathyroidism
- VDI
Intervention
- Drug: CTAP101
Primary outcomes
what the primary-completion date above is the date OFApparent clearance (CL/F)
measured Up to 14 weeks
Volume of distribution (Vd/F)
measured Up to 14 weeks
Terminal elimination half-life (t1/2)
measured Up to 14 weeks
Incidence of treatment emergent adverse events (TEAE)
measured Up to 14 weeks
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