OnychomycosisPhase 2NCT00679601
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
A Phase 2 study testing AN2690 in people with Onychomycosis, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to determine the absorption and systemic pharmacokinetics of AN2690 following daily application to all ten (10) toenails for 28 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- AN2690
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2007to 31 May 2007
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 and ≤65
- BMI between 18.5 and 35 inclusive
- Moderate to severe onychomycosis involving ≥80% of both great toenails, as determined by visual inspection after the nail has been trimmed
- Combined thickness of the nail plate and nail bed of each great toenail is >3mm
- At least 6 additional toenails with a clinical diagnosis of onychomycosis
- If a female of childbearing potential, must be using of a highly effective method of birth control or abstinence and be willing to remain on that same method of birth control throughout the study
- Capable of understanding and signing the informed consent, and willing to comply with all requirements of the study
Who cannot join
- History of allergy to any of the study drug 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
- Willing 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
- Failure to complete the specified washout period(s) for the following topical:
Show all 21Show fewer
- Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
- Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
- Failure to complete the specified washout period(s) for the following systemic medications:
- Corticosteroids (including intramuscular injections): 2 weeks
- Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
- 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 30 days prior to enrollment or participation in a research study concurrent with this study
- Prior enrollment in a study using the study drug, AN2690
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 and systemic pharmacokinetics of AN2690 following daily application to all ten (10) toenails for 28 days.
Read the detailed description
A single center, open-label, multiple-dose study design will be used. Planned enrollment is 20 subjects to complete 15. Subjects must have a clinical diagnosis of onychomycosis of each great toenail and a clinical diagnosis of onychomycosis of six of the remaining toenails.
- Conditions
- Onychomycosis
- Being tested
- AN2690
- Keywords
- Onychomycosis, Fungal Nail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN2690Drug
AN2690 7.5% Solution, once daily for 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time
Measured: Days 0, 1, 14, 15, and 28
Secondary outcomes (2)
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail growth
Measured: Days 0, 14, 28, and 42
Safety and tolerance assessed by application site reactions, adverse events, vital signs, physical examinations, and 12-lead EKG
Measured: Days 0-28, and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study start31 Mar 2007
- Primary completion31 May 2007
- Study completion31 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679601
- Sponsor's protocol ID
- AN2690-ONYC-205
- Other IDs
- C3371014
- Status last verified
- Feb 2018
- First submitted
- 15 May 2008
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00679601
- Acronym / sponsor ID
- AN2690-ONYC-205
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Fungal Nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2007 (actual)
- Primary completion
- 31 May 2007 (actual)
- Study completion
- 31 May 2007 (actual)
- First posted
- 19 May 2008 (estimated)
- 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.
The purpose of the study is to determine the absorption and systemic pharmacokinetics of AN2690 following daily application to all ten (10) toenails for 28 days.
Detailed description
A single center, open-label, multiple-dose study design will be used. Planned enrollment is 20 subjects to complete 15. Subjects must have a clinical diagnosis of onychomycosis of each great toenail and a clinical diagnosis of onychomycosis of six of the remaining toenails.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥18 and ≤65
- BMI between 18.5 and 35 inclusive
- Moderate to severe onychomycosis involving ≥80% of both great toenails, as determined by visual inspection after the nail has been trimmed
- Combined thickness of the nail plate and nail bed of each great toenail is >3mm
- At least 6 additional toenails with a clinical diagnosis of onychomycosis
Key exclusion criteria (21 listed)
- History of allergy to any of the study drug 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
- Willing 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
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 |
|---|---|---|
| AN2690AN2690 7.5% Solution, once daily for 28 days | Drug | – |
Primary outcome
Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time
Time frame: Days 0, 1, 14, 15, and 28
2 secondary outcomes
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail growth
Time frame: Days 0, 14, 28, and 42
Safety and tolerance assessed by application site reactions, adverse events, vital signs, physical examinations, and 12-lead EKG
Time frame: Days 0-28, and 42
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 20 Feb 2018.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AN2690 in people with Onychomycosis, run by Pfizer 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 7 inclusion and 21 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 20 Feb 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time (time frame: Days 0, 1, 14, 15, and 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2018.