Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CTAP101 Capsules, Calcifediol Oral Capsule
CTAP101 · 5 trials · 14 indications
Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
To determine the CL/F of CTAP101 Capsules during and after repeated dosing
To determine the Vd/F of CTAP101 Capsules during and after repeated dosing
To determine the t1/2 of CTAP101 Capsules during and after repeated dosing
TEAEs will be graded as mild, moderate, severe.
Incidence of AEs will be summarized by arm for all treatment-emergent AEs. Number and percent of participants with AEs will be summarized by system organ class and preferred term and presented overall and by arm.
Baseline finding will be measured against the different time points collected
Descriptive statistics will be calculated for PD assessment in the per protocol population.
Measured by the number of participants with treatment related adverse events and abnormal physical examinations, vital signs, clinical laboratory tests (hematology, coagulation, and clinical chemistry, urine calcium, albumin and creatinine), and 12-lead ECG.
| Arm | Type | Description |
|---|---|---|
| CTAP101 Capsules alone | EXPERIMENTAL | CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks |
| CTAP101 Capsules +calcitriol | EXPERIMENTAL | CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks |
| CTAP101 Capsules +doxercalciferol | EXPERIMENTAL | CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks |
| CTAP101 Capsules +paricalcitol | EXPERIMENTAL | CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks |
| Cohort 1 - Group A | EXPERIMENTAL | 30 mcg CTAP101 Capsules |
| Cohort 1 - Group B | EXPERIMENTAL | 30 mcg or 60 mcg CTAP101 Capsules |
| CTAP101 Capsules 450mcg/weekly fasted | EXPERIMENTAL | - |
| CTAP101 Capsules 900mcg/weekly fasted | EXPERIMENTAL | - |
| CTAP101 Capsules 1800mcg/weekly fasted | EXPERIMENTAL | - |
| CTAP101 Capsules 900mcg/weekly fed | EXPERIMENTAL | - |
| CTAP101 Capsules | EXPERIMENTAL | CTAP101 Capsules daily |
| Low Dose CTAP101 Capsules | EXPERIMENTAL | CTAP101 Capsules, 450 mcg dose |
| High Dose CTAP101 Capsules | EXPERIMENTAL | CTAP101 Capsules, 900 mcg dose |
| CTAP101 Injection | EXPERIMENTAL | IV injection, 448 mcg dose |
| Name | Type | Description |
|---|---|---|
| CTAP101 Capsules | DRUG | At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily |
| Calcitriol | DRUG | At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily |
| Doxercalciferol | DRUG | At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily |
| Paricalcitol | DRUG | At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily |
| CTAP101 | DRUG | Capsules |
| CTAP101 Injection | DRUG | single IV injection |
Inclusion Criteria: * Completed either of the phase 3 double-blind, placebo-controlled studies, CTAP101-CL-3001 or CTAP101-CL-3002 * Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this dose for the duration of the study * Taking no more than 1600 IU/dose vitamin D (er...
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CTAP101 is an investigational small molecule developed by Opko Health Inc. (ticker OPK). It is being studied in chronic kidney disease, vitamin D insufficiency, and certain cancers, including breast and prostate cancer. CTAP101 is also known as CTAP101 Capsules. It remains in clinical development and has not been approved by the FDA.
CTAP101 is being studied for vitamin D insufficiency and secondary hyperparathyroidism in chronic kidney disease, including CKD Stage 3, and for bone complications in patients with breast or prostate cancer receiving denosumab or zoledronic acid. These uses are investigational and have not been approved.
CTAP101 targets calcifediol, the circulating form of vitamin D. As a small molecule, it is designed to deliver calcifediol to raise vitamin D levels and manage secondary hyperparathyroidism in chronic kidney disease and related conditions. Its clinical benefit is still being evaluated in trials.
CTAP101 is developed by Opko Health Inc., which trades under the ticker OPK. The company sponsors the clinical program studying CTAP101 Capsules across chronic kidney disease, vitamin D insufficiency, and oncology-related bone complications.
CTAP101 is in Phase 1 development overall, though individual studies have been conducted in Phase 2 and Phase 3. It is investigational and has not been approved by the FDA. A Phase 2 pediatric study, NCT07494045, is currently recruiting, while several earlier trials have been completed.
CTAP101 trials include NCT07494045, a recruiting Phase 2 pharmacokinetic and safety study in pediatric participants with CKD Stage 3 or 4 and secondary hyperparathyroidism, and NCT03660800, a completed Phase 1 study in healthy Japanese and non-Japanese subjects. Completed studies also include NCT02282813 and NCT02274623.
Yes, CTAP101 Capsules is another name for CTAP101. Both refer to the same investigational extended-release calcifediol product developed by Opko Health Inc. (ticker OPK) for chronic kidney disease, vitamin D insufficiency, and related conditions.