PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.

Official Title
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Pharmacokinetics and Pharmacodynamics of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 14 Days Under Conditions of Maximal Use in Pediatric Subjects (2 to 12 Years of Age) With Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Calcitriol 3 mcg/g ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female pediatric subjects, 2 to 12 years of age inclusive at screening Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp) Exclusion Criteria: Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection Vitamin D deficiency at screening Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening Subjects with secondary hyperparathyroidism at screening

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol 3 mcg/g ointment<br>Topical application every 12 hours for 14 consecutive days | Drug: Calcitriol 3 mcg/g ointment<br>* Topical ointment; twice daily application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Calcitriol Plasma Level | Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14) | Day 14 | 
| Cmin of Calcitriol Plasma Level | Cmin of calcitriol plasma level at Day 14 | Day 14 | 
| Tmax of Calcitriol Plasma Level | Tmax of calcitriol plasma level at Day 14 | Day 14 | 
| AUC (0-6h) of Calcitriol Plasma Level | AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose) | Day 14 | 
| AUC (0-9h) of Calcitriol Plasma Level | AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.) | Day 14 | 
| AUC (0-12h) of Calcitriol Plasma Level | AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.) | Day 14 |