Brief Summary
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.
Brief Title
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Categories
Completion Date
Completion Date Type
Actual
Conditions
Plaque Psoriasis
Eligibility Criteria
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
* 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
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
12 Years
Minimum Age
2 Years
NCT Id
NCT01766440
Org Class
Industry
Org Full Name
Galderma R&D
Org Study Id
RD.06. SPR.18104
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Outcome Measure
Cmax of Calcitriol Plasma Level
Outcome Time Frame
Day 14
Outcome Description
Cmin of calcitriol plasma level at Day 14
Outcome Measure
Cmin of Calcitriol Plasma Level
Outcome Time Frame
Day 14
Outcome Description
Tmax of calcitriol plasma level at Day 14
Outcome Measure
Tmax of Calcitriol Plasma Level
Outcome Time Frame
Day 14
Outcome Description
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
Outcome Measure
AUC (0-6h) of Calcitriol Plasma Level
Outcome Time Frame
Day 14
Outcome Description
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.)
Outcome Measure
AUC (0-9h) of Calcitriol Plasma Level
Outcome Time Frame
Day 14
Outcome Description
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.)
Outcome Measure
AUC (0-12h) of Calcitriol Plasma Level
Outcome Time Frame
Day 14
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
12
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Cohen
Investigator Email
steven.cohen@aya.yale.edu
Investigator Phone