Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis

Medimetriks Pharmaceuticals, Inc32 enrolled

Overview

The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.

This is a multi-center, open-label study to assess the degree of systemic exposure and safety of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

MM36 topical ointment, 1%DRUG

Twice daily application for 28 consecutive days

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects 2 to \<18 years of age * Diagnosis of atopic dermatitis (AD) * AD affecting ≥ 35% body surface area (BSA) if 2 to \< 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas) Exclusion Criteria: * Active or acute viral skin infection * History of recurrent bacterial infection * Malignancy * Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments

Locations (12)

Medimetriks Investigational Site

Fremont, California, United States

Medimetriks Investigational Site

Irvine, California, United States

Medimetriks Investigational Site

San Diego, California, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of MM36

Maximum observed plasma concentration of MM36 on Day 1

Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

Maximum Observed Plasma Concentration (Cmax) of MM36

Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)

Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Time of Maximum Observed Plasma Concentration (Tmax) of MM36

Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1

Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

Time of Maximum Observed Plasma Concentration (Tmax) of MM36

Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15

Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36

Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1

Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36

Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15

Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Secondary Outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Medimetriks Investigational Site

Miami, Florida, United States

Medimetriks Investigational Site

Saint Joseph, Missouri, United States

Medimetriks Investigational Site

Portland, Oregon, United States

Medimetriks Investigational Site

Austin, Texas, United States

Medimetriks Investigational Site

Houston, Texas, United States

Medimetriks Investigational Site

Norfolk, Virginia, United States

Medimetriks Investigational Site

Spokane, Washington, United States

...and 2 more locations

Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: up to 4 weeks

Treatment-Emergent Adverse Events (AEs) According to Severity

Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.

Time frame: up to 4 weeks

Application Site Adverse Events (AEs)

Number of Participants With Application Site Adverse Events (AEs)

Time frame: up to 4 weeks

Application Site Adverse Events (AEs) According to Severity

Number of Participants With Application Site Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.

Time frame: up to 4 weeks

Clinically Meaningful Laboratory Test Median Changes From Baseline

Number of Participants With Clinically Meaningful Laboratory Test Median Changes From Baseline. Clinical meaningfulness of laboratory test changes was determined at the investigator's discretion.

Time frame: Day 29

Clinically Meaningful Vital Sign Median Changes From Baseline

Number of Participants With Clinically Meaningful Vital Sign Median Changes From Baseline. Clinical meaningfulness of vital sign changes was determined at the investigator's discretion.

Time frame: Day 29

Clinically Meaningful ECG Median Changes From Baseline to Day 15

Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

Time frame: Day 15

Clinically Meaningful ECG Median Changes From Baseline to Day 29

Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

Time frame: Day 29