- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244280
A Study of the Systemic Absorption of MOB015B
May 2, 2018 updated by: Moberg Pharma AB
A Study of the Systemic Absorption of Once Daily MOB015B When Applied for 28 Days in Subjects With Moderate to Severe Onychomycosis of the Toenails.
A Study of the Systemic Absorption of Once Daily MOB015B when Applied for 28 Days in Subjects with Moderate to Severe Onychomycosis of the Toenails.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
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
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Texas
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Austin, Texas, United States, 78759
- Dermatology Clinic
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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
12 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who understand the study procedures and agree to participate by providing written informed consent. Subject must be willing to authorize use and disclosure of protected health information collected for the study.
- Male or female subjects 12 to 70 years of age (inclusive), at the time of consent.
- Subject has a body mass index (BMI) from ≥ 18.5 to ≤ 35.0 (kg/m2), at the screening visit.
- Females of childbearing potential must be using contraception during the study which can include abstinence or hormonal contraceptives. All women of childbearing potential must be willing to complete a urine pregnancy test on Days 1, 14, and 28.
- Subjects must present with a clinical diagnosis of moderate to severe subungal onychomycosis with at least 50% involvement of both great toenails. In addition, 4 other toenails must be affected.
- Subjects must have a positive KOH microscopy for at least 1 great toenail at the screening visit.
- Subjects must be willing to complete clinical laboratory testing.
- Subjects must be willing to undergo alcohol and drug (e.g., benzodiazepines, cocaine, opioids, cannabinoids, and barbiturates) tests at the Day 1 visit.
- Subjects must be willing to remain at the study site for approximately 11 hours and undergo multiple blood draws on Day 1 and 28.
- Subjects must be able to reach their toes to apply study drug or have a caregiver willing to help apply the study drug on a daily basis as directed.
Exclusion Criteria:
- Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period.
- Subjects with chronic or active liver disease, renal impairment, cutaneous or systematic lupus erythematosus, or any other disease or medical condition that in the opinion of the investigator would interfere with the study or place the subject at undue risk.
- Subject with hypersensitivity to terbinafine or the vehicle excipients.
- Subjects who have been treated with systematic formulations of terbinafine in the 12 months prior to the Day 1 visit.
- Subjects who have been treated with topical formulations of terbinafine in the 6 months prior to the day 1 visit.
- Subjects who take or have taken systematic medication that may interfere with the study or place the subject at undue risk in the 30 days before the day 1 visit (e.g., rifampin, cimetidine, phenobarbital, phenytoin, carbamazepine, terfenadine or digoxin).
- Subjects who take or have taken systemic medication in the 30 days before the Day 1 visit that interferes with the terbinafine plasma assay.
- Subjects who have consumed grapefruit products during the 30 days prior to the Day 1 visit.
- Subjects who are not willing to refrain from caffeinated beverage consumption on Day 1 and 28.
- Subjects with a current history of consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to Day 1 visit (one drink is equal to one unit of alcohol, one glass of wine, half pint of beer or one ounce of spirits).
- Subjects with an ongoing or recent history of treatment for substance abuse.
- Subjects who have participated in a study of an investigational drug 60 days prior to the Day 1 visit.
- Subjects with a history of multiple syncopal episodes.
- Subjects with positive tests for drugs or alcohol at Day 1 visit.
- Subjects who are unable to comply with study requirements.
- Subjects who are not willing to abstain from all toenail treatments such as toenail polish, pedicures and/or foot soaks (including nail clipping or debridement), for 3 days prior to Day 1 visit and during the study.
Donation of blood (one unit or 350 mL) within 90 days prior to Day 1 visit.
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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: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: MOB015B
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Topical formulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the Cmax
Time Frame: 28 days
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To measure the Cmax after 1 day and 28 days
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28 days
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To measure the Tmax
Time Frame: 28 days
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To measure Tmax after 1 day and 28 days
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28 days
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to measure AUC0-t
Time Frame: 28 days
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To measure AUC0-t after 1 day and 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 16, 2017
Primary Completion (ACTUAL)
April 23, 2018
Study Completion (ACTUAL)
April 23, 2018
Study Registration Dates
First Submitted
August 1, 2017
First Submitted That Met QC Criteria
August 8, 2017
First Posted (ACTUAL)
August 9, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2018
Last Update Submitted That Met QC Criteria
May 2, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOB015B-VIII
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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