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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01766440

Enrollment

Registered

2013-01-11

Start date

2013-03-31

Completion date

2015-11-30

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

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.

Interventions

DRUGCalcitriol 3 mcg/g ointment

Topical ointment; twice daily application

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cmax of Calcitriol Plasma Level	Day 14	Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Cmin of Calcitriol Plasma Level	Day 14	Cmin of calcitriol plasma level at Day 14
Tmax of Calcitriol Plasma Level	Day 14	Tmax of calcitriol plasma level at Day 14
AUC (0-6h) of Calcitriol Plasma Level	Day 14	AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
AUC (0-9h) of Calcitriol Plasma Level	Day 14	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.)
AUC (0-12h) of Calcitriol Plasma Level	Day 14	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.)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Calcitriol 3 mcg/g Ointment Topical application every 12 hours for 14 consecutive days Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application	18
Total	18

Baseline characteristics

Characteristic	Calcitriol 3 mcg/g Ointment
Age, Continuous	8.4 years STANDARD_DEVIATION 3
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	9 / 18
serious Total, serious adverse events	0 / 18

Outcome results

Primary

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.)

Time frame: Day 14