Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)

February 20, 2019 updated by: Pfizer

An Open-label, Multiple-dose Study Of The Absorption And Systemic Pharmacokinetics Of An2690 Applied As A 7.5% Solution To All Toenails Of Adult Patients With Moderate To Severe Onychomycosis

The purpose of the study is to determine the absorption, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with onychomycosis.

Study Overview

Status

Completed

Conditions

Onychomycosis

Intervention / Treatment

Drug: AN2690

Detailed Description

For this study, the case definition of onychomycosis included moderate to severe distal subungual onychomycosis including subjects with evidence of subungual dermatophytoma or yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates. Subjects with only superficial white onychomycosis were excluded. Confirmation of the clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet mount.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Bryan, Texas, United States, 77802
    - J&S Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

A witnessed, signed informed consent approved by Institutional Review Board
Male or female of any race at least 18 years of age but not older than 65 years of age at the time of screening
Body Mass Index between 18.5 and 35, inclusive
Onychomycosis involving > 80% of both great toenails, as determined by visual inspection after the nail has been trimmed
Each great toenail possess a combined thickness of the nail plate and nail bed > 3 mm
At least six additional toenails with clinical diagnosis of onychomycosis
A positive KOH wet mount for at least one great toenail
If subject is a female of childbearing potential, must be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
Considered reliable and capable of understanding his/her responsibility and role in the study

Exclusion Criteria:

History of allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
Clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety
Diabetes mellitus requiring treatment other than diet and exercise
Unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study
Nursing, pregnant or planning to become pregnant during the study
Has not undergone the specified washout period(s) for the following topical preparations or does the subject require the concurrent use of any of the following topical medications:
1. Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study: 4 weeks
2. Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
Has not undergone the specified washout period(s) for the following systemic medications or does the subject require the concurrent use of any of the following systemic medications:
1. Corticosteroids (including intramuscular injections): 2 weeks
2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
3. Systemic immunomodulators: 4 weeks
Received treatment of any type for cancer within the last 6 months
History of any significant internal disease
Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated
AIDS or AIDS related complex
History of street drug or alcohol abuse
Donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation
Donated plasma during the two week period preceding study initiation
Participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail Time Frame: Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 360	Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 360

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerance assessed by application site reactions, adverse events, laboratory tests, vital signs, physical examinations, and 12-lead EKG Time Frame: Days 0-28, 42, 84, 120, 150, 180, 240, 300, and 360	Days 0-28, 42, 84, 120, 150, 180, 240, 300, and 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2006

Primary Completion (ACTUAL)

May 9, 2007

Study Completion (ACTUAL)

May 9, 2007

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria