PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
Status:
Recruiting
Trial end date:
2023-02-28
Target enrollment:
Participant gender:
Summary
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of
spinosad and benzyl alcohol for 12 hours following a single, full-body topical application
(open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There
will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the
goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba™ will
be applied over the entire body from the neck down to the toes (including the soles of the
feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation
is present on the scalp). The open-label IP will remain on the skin for at least 6 hours
before removing the IP by gentle washing. The subjects will stay in the clinic until the
12-hour procedures are completed. Blood draws will be taken at 0 hours just prior to
treatment, and then at 0.5, 1.0, 3.0, 6.0- and 12-hours post-treatment. Heel sticks are
likely to be the mode of blood collection for children less than 2 years of age. Removal of
IP must occur after the 6-hour blood draw and at least 1 hour before 12-hour blood draw. A
±5-minute time window will be allowed for all post-treatment blood samples. Safety will be
assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose
and pre-discharge laboratory evaluations. Following the sample collections subjects will be
released from the clinic and directed to their primary care physician for follow-up. Subjects
will be provided scabies medications upon discharge to dispense to family members. These
include 5% Permethrin for those in the household that are less than 4 years of age and
NatrobaTM for those in the household 4 years of age and older. Subjects who terminate early
will not be given these medications to dispense to family members.
Phase:
Phase 4
Details
Lead Sponsor:
ParaPRO LLC
Collaborators:
Concentrics Research Inotiv Laboratories Medpace, Inc. MicroConstants, Inc. STATKING Clinical Services