Clinical trial NCT01652885: Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis
Official title: An Open-Label Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN2728 Ointment in Adolescents With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 23
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Male or female 12 to 17 years of age, inclusive
* Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
* AD in treatable areas (excludes the scalp and venous access areas) involving

  ≥10% and ≤35% of the total body surface area(BSA)
* Investigator's Static Global Assessment (ISGA) score of 2 or 3
* Normal or not clinically significant screening laboratory results
* Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site
* Willing and able to comply with study instructions and commit to attending all visits
* Females must use a highly effective method of birth control.
* Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion Criteria:

* Significant confounding conditions as assessed by study doctor
* Unstable or actively infected AD
* Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
* Current pregnancy or lactation, or intent to become pregnant during the study
* Known sensitivity to any of the components of the study drug
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Participated in a previous AN2728 clinical study

Primary outcomes:
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Baseline
timeFrame: Baseline
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 2
timeFrame: Day 2
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 4
timeFrame: Day 4
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 6
timeFrame: Day 6
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 8
timeFrame: Day 8
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 9
timeFrame: Day 9
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 15
timeFrame: Day 15
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 22
timeFrame: Day 22
measure: Number of Participants With Local Tolerability Symptoms According to Severity on Day 29
timeFrame: Day 29
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Day 29
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline (Day 1) up to Day 29
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: Baseline (Day 1) up to Day 29
measure: Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1
measure: Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1
measure: Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8
measure: Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8
measure: Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8
timeFrame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8
Secondary outcomes:
measure: Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA)
timeFrame: Baseline up to Day 29
measure: Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29
timeFrame: Baseline, Day 8, 15, 22, 29
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Anacor Investigational Site
state: California
city: San Diego
country: United States
facility: Anacor Investigational Site
state: California
city: Indianapolis
country: United States
facility: Anacor Investigational Site
state: Indiana
city: High Point
country: United States
facility: Anacor Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Anacor Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Anacor Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: