OnychomycosisPhase 1NCT01014962
A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus
A Phase 1 study testing Albaconozole in people with Onychomycosis, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Albaconozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2009to 4 Dec 2009
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects age 18 to 45
- A body mass index (BMI) between 18.5 and 30 kg/m2.
- Good physical and mental health.
- Vital signs .within the acceptable range.
- Electrocardiogram (12-lead) after at least 5 minutes in supine position considered as normal or with findings considered as not clinically significant by the investigator. .
- Non-smoker for at least 6 months before screening.
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- Subject has screening laboratory parameters within the normal ranges unless considered to be not clinically relevant by the principal investigator. .
- Subject is able to review and understand an informed consent, and must sign the independent ethics committee (IEC)/IRB approved informed consent form before any trial-related procedures are performed.
- Sexually active females of childbearing potential must have a negative serum pregnancy test result at screening. These subjects must use a medically acceptable method of contraception while receiving protocol-assigned product, and are expected to continue to use this method of contraception for up to 90 days following the last dose of the study medication. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.
- Women who are not currently sexually active or lactating must agree to use 2 forms of nonhormonal contraception, should they become sexually active while participating in the study, and for 90 days following the end of participation in the study. Male subjects and/or their partners must use a medically acceptable form of contraception while receiving protocol-assigned product, and up to 90 days following the last dose of the study medication.
- Subject is willing and able to take the assigned clinical trial medication as directed, comply with clinical trial instructions, and commit to all study visits.
Who cannot join
- History of intolerance to any of the ingredients in the study medications, or other related drugs, or history of relevant/clinically significant allergic reactions of any origin.
- Any disease or physical condition that, in the opinion of the investigator, could impact the PK/pharmacodynamics of the drug or could potentially compromise the safety of the subject.
- Subject has previously participated in a clinical study of albaconazole.
- History of drug, prescription medicine, or alcohol abuse within the past 2 years.
- Positive drug screen.
- History of psychological or other emotional problems that are likely to invalidate informed consent, or could limit the ability of the subject to comply with the protocol requirements.
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- Any drug treatment taken within 14 days before the first drug intake or within 5 half-lives whichever is longer.
- Participation in another clinical trial, blood donation, or significant blood loss less than 30 days before the first intake of study drug.
- Unsuitable veins for repeated venipuncture.
- Subject has any known liver disease or liver toxicity with other drugs.
- Subject has a predose ECG before dosing with a QTcB or QTcF interval >450 msec, or abnormal morphology of the ECG, or clinically serious arrhythmia.
- Subjects who are pregnant, breast-feeding, women of childbearing potential not using adequate contraceptives or planning to conceive, or male subjects who plan to father a child as described in the informed consent.
- Positive for hepatitis B (HBsAg) or hepatitis C (Ab HCV) or HIV or AIDS.
- Consumption of any excluded drugs or foodstuff within 72 hours before dosing.
- Subjects who are employees of a clinical research organization involved in the study, or Stiefel, or an immediate family member.
- Subjects who have a member of the same household in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Tolerability And Pharmacokinetic Study Of Escalating Doses Of Albaconazole In Healthy Subjects
The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.
Read the detailed description
This study aims to evaluate the safety and tolerability of 5 days of albaconazole dosing at levels that exceed both the projected therapeutic dose and the projected therapeutic frequency, in order to identify an upper dose for administration in a TQTc study. It also aims to assess the pharmacokinetics of multiple escalating doses of albaconazole, and to assess the effects of multiple and sustained dosing of high doses of albaconazole on ECG parameters.
- Conditions
- Onychomycosis
- Being tested
- Albaconozole, Placebo
- Keywords
- Pharmacokinetic, tolerability, multiple escalating doses
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbaconozoleDrug
Albaconozole 400 mg oral once daily for 5 days
PlaceboDrug
Placebo oral once daily for 5 days
AlbaconozoleDrug
Albaconozole 400 mg every 12 hours for 5 days
PlaceboDrug
Placebo oral every 12 hours for 5 days
AlbaconozoleDrug
Albaconozole 400 mg oral every 8 hours for 5 days
PlaceboDrug
Placebo oral every 8 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Albaconazole 400 mg cohort 1 | Experimental | Albaconazole 400 mg Receives: Drug: Albaconozole |
| Placebo cohort 1 | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
| Albaconozole 400 mg cohort 2 | Experimental | Albaconozole 400 mg every 12 hours Receives: Drug: Albaconozole |
| Placebo cohort 2 | Placebo comparator | Placebo every 12 hours Receives: Drug: Placebo |
| Albaconozole 400 mg cohort 3 | Experimental | Albaconozole 400 mg every 8 hours Receives: Drug: Albaconozole |
| Placebo cohort 3 | Placebo comparator | Placebo every 8 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of albaconazole in subjects
Measured: During 5 days of dosing and 15 days follow-up
Secondary outcomes (1)
Electrocardiogram (ECG) QTc values
Measured: During 5 days of dosing and 15 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study start24 Aug 2009
- Primary completion4 Dec 2009
- Study completion4 Dec 2009
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014962
- Sponsor's protocol ID
- 114555
- Status last verified
- Jun 2017
- First submitted
- 16 Nov 2009
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Tolerability And Pharmacokinetic Study Of Escalating Doses Of Albaconazole In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01014962
- Acronym / sponsor ID
- 114555
- Conditions
- Onychomycosis
- Keywords
- Pharmacokinetic, tolerability, multiple escalating doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 24 Aug 2009 (actual)
- Primary completion
- 4 Dec 2009 (actual)
- Study completion
- 4 Dec 2009 (actual)
- First posted
- 17 Nov 2009 (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 this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.
Detailed description
This study aims to evaluate the safety and tolerability of 5 days of albaconazole dosing at levels that exceed both the projected therapeutic dose and the projected therapeutic frequency, in order to identify an upper dose for administration in a TQTc study. It also aims to assess the pharmacokinetics of multiple escalating doses of albaconazole, and to assess the effects of multiple and sustained dosing of high doses of albaconazole on ECG parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Albaconazole 400 mg cohort 1 | Experimental | Drug: AlbaconozoleAlbaconazole 400 mg |
| Placebo cohort 1 | Placebo comparator | Drug: PlaceboPlacebo once daily |
| Albaconozole 400 mg cohort 2 | Experimental | Drug: AlbaconozoleAlbaconozole 400 mg every 12 hours |
| Placebo cohort 2 | Placebo comparator | Drug: PlaceboPlacebo every 12 hours |
| Albaconozole 400 mg cohort 3 | Experimental | Drug: AlbaconozoleAlbaconozole 400 mg every 8 hours |
| Placebo cohort 3 | Placebo comparator | Drug: PlaceboPlacebo every 8 hours |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female subjects age 18 to 45
- A body mass index (BMI) between 18.5 and 30 kg/m2.
- Good physical and mental health.
- Vital signs .within the acceptable range.
- Electrocardiogram (12-lead) after at least 5 minutes in supine position considered as normal or with findings considered as not clinically significant by the investigator. .
Key exclusion criteria (16 listed)
- History of intolerance to any of the ingredients in the study medications, or other related drugs, or history of relevant/clinically significant allergic reactions of any origin.
- Any disease or physical condition that, in the opinion of the investigator, could impact the PK/pharmacodynamics of the drug or could potentially compromise the safety of the subject.
- Subject has previously participated in a clinical study of albaconazole.
- History of drug, prescription medicine, or alcohol abuse within the past 2 years.
- Positive drug screen.
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 |
|---|---|---|
| AlbaconozoleAlbaconozole 400 mg oral once daily for 5 days | Drug | Albaconazole 400 mg cohort 1 |
| PlaceboPlacebo oral once daily for 5 days | Drug | Placebo cohort 1 |
| AlbaconozoleAlbaconozole 400 mg every 12 hours for 5 days | Drug | Albaconozole 400 mg cohort 2 |
| PlaceboPlacebo oral every 12 hours for 5 days | Drug | Placebo cohort 2 |
| AlbaconozoleAlbaconozole 400 mg oral every 8 hours for 5 days | Drug | Albaconozole 400 mg cohort 3 |
| PlaceboPlacebo oral every 8 hours for 5 days | Drug | Placebo cohort 3 |
Primary outcome
Plasma concentrations of albaconazole in subjects
Time frame: During 5 days of dosing and 15 days follow-up
1 secondary outcome
Electrocardiogram (ECG) QTc values
Time frame: During 5 days of dosing and 15 days follow-up
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 Jun 2017.
- Results for study 114555 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Albaconozole in people with Onychomycosis, run by Stiefel, a GSK Company 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 11 inclusion and 16 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 Jun 2017. 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. Some participants in this study may receive a placebo. 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?
Plasma concentrations of albaconazole in subjects (time frame: During 5 days of dosing and 15 days follow-up). 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 Jun 2017.