OnychomycosisPhase 1NCT03244280
A Study of the Systemic Absorption of MOB015B
A Phase 1 study testing MOB015B in people with Onychomycosis, run by Moberg Pharma AB at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- MOB015B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2017to 23 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Onychomycosis
- Being tested
- MOB015B
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOB015BDrug
Topical formulation
| Study group | Role | What they receive |
|---|---|---|
| MOB015B | Other | Not described Receives: Drug: MOB015B |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the Cmax
To measure the Cmax after 1 day and 28 days
Measured: 28 days
To measure the Tmax
To measure Tmax after 1 day and 28 days
Measured: 28 days
to measure AUC0-t
To measure AUC0-t after 1 day and 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start16 Dec 2017
- Primary completion23 Apr 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244280
- Sponsor's protocol ID
- MOB015B-VIII
- Status last verified
- May 2018
- First submitted
- 1 Aug 2017
- Last updated
- 3 May 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tavakkol A, DuBois JC, Gupta AK. Systemic absorption and safety of topical terbinafine hydrochloride 10% solution (MOB015B): a phase 1 maximal usage trial in patients with moderate-to-severe onychomycosis. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0068224. doi: 10.1128/aac.00682-24. Epub 2024 Aug 19.
PubMed 39158295
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03244280
- Acronym / sponsor ID
- MOB015B-VIII
- Conditions
- Onychomycosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOB015B | Other | Drug: MOB015B |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOB015BTopical formulation | Drug | MOB015B |
Primary outcome
To measure the Cmax
Time frame: 28 days
To measure the Cmax after 1 day and 28 days
To measure the Tmax
Time frame: 28 days
To measure Tmax after 1 day and 28 days
to measure AUC0-t
Time frame: 28 days
To measure AUC0-t after 1 day and 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 39158295Tavakkol A, DuBois JC, Gupta AK. Systemic absorption and safety of topical terbinafine hydrochloride 10% solution (MOB015B): a phase 1 maximal usage trial in patients with moderate-to-severe onychomycosis. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0068224. doi: 10.1128/aac.00682-24. Epub 2024 Aug 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MOB015B in people with Onychomycosis, run by Moberg Pharma AB at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the Cmax (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.