PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies

NCT05310734 | Recruiting Phase 4 FDA Drug

• 1 other identifier: SPN-110-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 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 Investigational Product (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 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. 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 Natroba 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.

Conditions

Scabies

Keywords

Pharmacokinetics; PK; Pharmacokinetics and Safety Study of Spinosad; PK and Safety Study of Spinosad; Spinosad PK and Safety Study; Safety; Pharmacokinetic and Safety Study of Natroba; PK and Safety Study of Natroba; Natroba PK and Safety Study

Outcome Measures

Primary Outcomes (12)

• Cmax for Spinosyn A

  Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Tmax for Spinosyn A

  The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Area Under the Curve (AUC) 0-3 for Spinosyn A

  Area under the plasma concentration versus time curve Area Under the Curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Cmax for Spinosyn D

  Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Tmax for Spinosyn D

  The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Area Under the Curve (AUC) 0-3 for Spinosyn D

  Area under the plasma concentration versus time curve Area Under the Curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Cmax for Benzyl Alcohol

  Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Tmax for Benzyl Alcohol

  The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Area Under the Curve (AUC) 0-3 for Benzyl Alcohol

  Area under the plasma concentration versus time curve Area Under the Curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.

  Blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.

• Treatment Emergent Adverse Events

  Treatment emergent AEs will be coded using MedDRA and summarized by System Organ Class and Preferred Term.

  Through study completion, 3 hours

• Change in General Skin Irritation

  The skin assessment will include documentation of presence or absence of irritation.

  Through study completion, 3 hours

• Change in General Eye Irritation

  The eye assessment will include documentation of presence or absence of irritation with a rating scale 0-3. 0 - no irritation, 1 - mild scleral, lid and/or lid injection with conjuctival erythema; 2 - moderate scleral and/or lid injection with conjunctival erythema; 3 - severe scleral and/or lid injection with conjunctival erythema and purulent drainage.

  Through study completion, 3 hours

Study Arms (1)

PK and Safety

EXPERIMENTAL

A Single 6-hour Treatment, Pharmacokinetic and Safety Study of Natroba (spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age with an Active Scabies Infestation.

Drug: Spinosad Topical

Interventions

Spinosad Topical DRUG

A topical suspension indicated for the treatment of scabies is used for this PK and Safety Study

Also known as: Natroba, benzyl alcohol

PK and Safety

Eligibility Criteria

• Age: 1 Month - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, ages 1 month to 3 years and 11 months.
• Must have active scabies infestation confirmed by clinical signs and symptoms (evidence of burrows or presence of scabies inflammatory/non-inflammatory lesions and pruritus) as well as by burrow ink test (BIT) to demonstrate the presence of burrowing mites.
• Generally, in good health based on medical history and clinical assessments.
• Normal-appearing skin in non-infested areas.
• No history of chronic or recurrent dermatologic disease.
• Willingness to comply with the study procedures including blood collections and application of study treatment in-clinic.

You may not qualify if:

• Presence of crusted scabies (Norwegian scabies).
• Allergies or intolerance to ingredients in the Investigational Product.
• Known renal or hepatic impairment.
• Treatment with scabicide within the prior 2 weeks.
• Immunodeficiency (including HIV infection) as reported in Medical History.
• Signs or symptoms of systemic infection.
• Administration of systemic therapy for infectious disease within the prior 2 weeks.
• Receipt of any investigational product within the prior 4 weeks.
• Medications used for itching or other indication that contain benzyl alcohol or other alcohols within the past 7 days.
• Over-the-counter cortisone products within the past 7 days.
• Oral prescription medications and/or antibiotics within the past 7 days.
• Any other conditions that, at the investigator's discretion, may interfere with the study conduct, or which might confound the interpretation of the study results, or which may put the subject at undue risk.

Sponsors & Collaborators

• Cipher Pharmaceuticals Inc.: lead
• Concentrics Research: collaborator
• Iqvia Pty Ltd: collaborator
• Medpace, Inc.: collaborator
• Inotiv Laboratories: collaborator
• BioAgilytix: collaborator

Study Sites (3)

L&C Professional Medical Research Institute

Miami, Florida, 33144, United States

RECRUITING

Velocity Clinical Research

Lafayette, Louisiana, 70508, United States

RECRUITING

Elixir Research Group

Houston, Texas, 77077, United States

RECRUITING

MeSH Terms

Conditions

Scabies

Interventions

spinosad; Benzyl Alcohol

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzyl Alcohols; Alcohols; Organic Chemicals; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sharda Angl

  Cipher Pharmaceuticals Inc.

  STUDY DIRECTOR

• Julie Aker, MT(ASCP)

  Concentrics Research

  STUDY CHAIR

• William Miller, MD

  Concentrics Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharda Angl

CONTACT

905-602-5840; sangl@cipherpharma.com

Nina Garrett

CONTACT

800-800-5525; nina.garrett@concentricsresearch.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A blood draw will be taken from subjects just before a full body spinosad application (t=0) and then at 0.5 and 3.0 hours. The following PK parameters will be calculated for spinosad (spinosyn A and spinosyn D) and benzyl alcohol in each subject: Cmax, Tmax, and Area Under the Curve (AUC) 0-3h. Safety assessments include monitoring of AEs, general skin and eye irritation, laboratory assessments, prior medications, and concomitant medications. Smaller laboratory blood samples will be collected pre-dose and 3-hours post-dose prior to discharge.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 5, 2022
• Study Start: March 4, 2022
• Primary Completion: November 30, 2025
• Study Completion: March 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)