NCT07494045Phase 2Recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-10Estimated

Enrollment · participants40Estimated

Source updated2026-08-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-20 · 1 field changed

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

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Study details

Conditions studied

CKD Stage 3; CKD Stage 4; Secondary Hyperparathyroidism; VDI

Treatments or interventions studied

CTAP101Drug

Primary outcomes · main study measures

Read the study measures

measure: Apparent clearance (CL/F); description: To determine the CL/F of CTAP101 Capsules during and after repeated dosing; timeFrame: Up to 14 weeks; measure: Volume of distribution (Vd/F); description: To determine the Vd/F of CTAP101 Capsules during and after repeated dosing; timeFrame: Up to 14 weeks; measure: Terminal elimination half-life (t1/2); description: To determine the t1/2 of CTAP101 Capsules during and after repeated dosing; timeFrame: Up to 14 weeks; measure: Incidence of treatment emergent adverse events (TEAE); description: TEAEs will be graded as mild, moderate, severe.; timeFrame: Up to 14 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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