OnychomycosisPhase 1NCT01039883
A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule
A Phase 1 study testing Albaconazole tablet 400mg and Albaconazole 100mg capsules, then albaconazole 400mg tablet 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 whether albaconazole tablets and albaconazole capsules (single 400mg dose) act in the body in the same way over a period of time. 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?
- Albaconazole tablet 400mg and Albaconazole 100mg capsules, then albaconazole 400mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2009to 20 Jan 2010
- 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
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Male or female aged from 18 to 45 years at time of consent and at time of first dose.
- A body mass index (BMI) between 18.5 and 30 kg/m2.
- Able to complete the study and to comply with study instructions.
- Free of clinically significant disease as determined by history, physical examination, and laboratory testing.
- The subject is a non-smoker or ex-smoker. If a subject is an ex smoker, he/she must not have used nicotine for at least 6 months before first dose.
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- The screening and baseline laboratory parameters must be within normal ranges unless agreed as not clinically relevant by the principal investigator and the sponsor. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin values should be lower than 1.5 times the upper normal limit at screening.
- The subject will have negative results for the following tests at screening:
- Hepatitis B surface antigen (HBsAg)
- Hepatitis B core antibodies (HBcAc)
- Anti-hepatitis C virus (Anti-HCV)
- Human immunodeficiency virus (HIV) antibody test
- Urine drug screen
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and until 30 days following the last dose of the study product. 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. Acceptable contraceptive methods include the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
- Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide are acceptable.
- Women who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception
Who cannot join
- Female who is pregnant (positive pregnancy test), trying to become pregnant, or breast feeding.
- Received any investigational drug within 30 days of study day 1 or who are scheduled to receive an investigational drug other than the study product during the study.
- Used prescription drug therapy, over the counter (nonprescription) medications, recreational drugs, or herbal products within 30 days of dosing, unless agreed as not clinically relevant by the principal investigator and sponsor.
- Participated in a previous study of the same study product.
- Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- Currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
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- Has a history of anemia, iron deficiency, or iron depletion.
- Has a history of any condition possibly affecting absorption of drug (eg, peptic ulcer disease, gastrectomy, intestinal malabsorption).
- Considered immunocompromised.
- History of drug, prescription medicine, or alcohol abuse within the past 2 years.
- Has a history of known or suspected intolerance to any of the ingredients of the study products.
- Has known drug allergies.
- Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Intends to donate blood or blood components while receiving the study product or for the duration of the pharmacokinetic sampling period.
- Has donated blood or has had significant blood loss (≥250 mL) within 30 days before dosing or has donated plasma within 7 days before dosing.
- Has QT interval corrected for heart rate (Fridericia's correction formula) (QTcF) >450 ms or any ECG abnormality except for the following:
- Mild sinus bradycardia in younger, athletic subjects (heart rate down to 46 beats per minute allowed).
- Mild sinus arrhythmia.
- Mild first degree atrioventricular (A-V) block (P-R interval <0.23 sec).
- Mild right or left axis deviation.
- Incomplete right bundle branch block.
- Isolated left anterior fascicular block (left anterior hemiblock) in younger, athletic subjects.
- Early repolarization.
- Uncorrected QT interval or QT interval corrected for heart rate with Bazett's correction formula (QTcB) exceeding 450 ms, with a QTcF ≤450 ms.
- Considered unable or unlikely to attend the necessary visits.
- Employees of investigator/ clinical research organization or Stiefel involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Clinical Research Center
Buffalo, New York, 14202
About this study
Official title: A Phase 1, Randomized, Open-Label, Crossover Safety and Pharmacokinetic Study of 400 mg Albaconazole as a Tablet Formulation Versus a Capsule Formulation in Healthy Subjects
The purpose of this study is to determine whether albaconazole tablets and albaconazole capsules (single 400mg dose) act in the body in the same way over a period of time.
Read the detailed description
The aim of this study is to compare the bioavailability of the formulation used in earlier clinical studies (albaconazole capsules) with the formulation intended for use in further development (albaconazole tablets). The study is also designed to assess the safety and tolerability of a single oral dose of albaconazole tablets (400 mg), and assess the bioequivalence of albaconazole tablets with albaconazole capsules.
- Conditions
- Onychomycosis
- Being tested
- Albaconazole tablet 400mg, Albaconazole 100mg capsules, then albaconazole 400mg tablet
- Keywords
- Healthy Volunteers
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albaconazole tablet 400mgDrug
Also called Albaconazole
Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose
Albaconazole 100mg capsules, then albaconazole 400mg tabletDrug
Also called Albaconazole
Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects randomized to study product sequence 1 will receive the single albaconazole 400-mg tablet during the first dosing period and the four 100-mg albaconazole capsules during the second dosing period. Receives: Drug: Albaconazole tablet 400mg |
| 2 | Experimental | Subjects randomized to study product sequence 2 will receive the four 100-mg albaconazole capsules during the first dosing period and the single albaconazole 400-mg tablet during the second dosing period. Receives: Drug: Albaconazole 100mg capsules, then albaconazole 400mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of albaconazole
Measured: Blood samples taken predose and at 30 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (day 1 time points), 18 (day 2), 24 (day 2), hours post-dose and once a day on days 3-16
Secondary outcomes (1)
Safety and tolerability of a single oral dose of 400mg albaconazole tablet
Measured: ECGs and lab tests at screening, pre-dose, and 3 hours, and 16 days post-dose. Physical examination at screening, pre-dose and 16 days post-dose. Assessment of adverse events from consent to 16 days post-dose (second dosing period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study start23 Nov 2009
- Primary completion20 Jan 2010
- Study completion20 Jan 2010
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01039883
- Sponsor's protocol ID
- 114563
- Status last verified
- Jun 2017
- First submitted
- 23 Dec 2009
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
van Rossem K, Lowe JA. A Phase 1, randomized, open-label crossover study to evaluate the safety and pharmacokinetics of 400 mg albaconazole administered to healthy participants as a tablet formulation versus a capsule formulation. Clin Pharmacol. 2013;5:23-31. doi: 10.2147/CPAA.S39600. Epub 2013 Jan 30.
PubMed 23390369
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Crossover Safety and Pharmacokinetic Study of 400 mg Albaconazole as a Tablet Formulation Versus a Capsule Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01039883
- Acronym / sponsor ID
- 114563
- Conditions
- Onychomycosis
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 23 Nov 2009 (actual)
- Primary completion
- 20 Jan 2010 (actual)
- Study completion
- 20 Jan 2010 (actual)
- First posted
- 25 Dec 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 whether albaconazole tablets and albaconazole capsules (single 400mg dose) act in the body in the same way over a period of time.
Detailed description
The aim of this study is to compare the bioavailability of the formulation used in earlier clinical studies (albaconazole capsules) with the formulation intended for use in further development (albaconazole tablets). The study is also designed to assess the safety and tolerability of a single oral dose of albaconazole tablets (400 mg), and assess the bioequivalence of albaconazole tablets with albaconazole capsules.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Albaconazole tablet 400mgSubjects randomized to study product sequence 1 will receive the single albaconazole 400-mg tablet during the first dosing period and the four 100-mg albaconazole capsules during the second dosing period. |
| 2 | Experimental | Drug: Albaconazole 100mg capsules, then albaconazole 400mg tabletSubjects randomized to study product sequence 2 will receive the four 100-mg albaconazole capsules during the first dosing period and the single albaconazole 400-mg tablet during the second dosing period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Male or female aged from 18 to 45 years at time of consent and at time of first dose.
- A body mass index (BMI) between 18.5 and 30 kg/m2.
- Able to complete the study and to comply with study instructions.
- Free of clinically significant disease as determined by history, physical examination, and laboratory testing.
Key exclusion criteria (26 listed)
- Female who is pregnant (positive pregnancy test), trying to become pregnant, or breast feeding.
- Received any investigational drug within 30 days of study day 1 or who are scheduled to receive an investigational drug other than the study product during the study.
- Used prescription drug therapy, over the counter (nonprescription) medications, recreational drugs, or herbal products within 30 days of dosing, unless agreed as not clinically relevant by the principal investigator and sponsor.
- Participated in a previous study of the same study product.
- Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
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 |
|---|---|---|
| Albaconazole tablet 400mgAlso: AlbaconazoleAlbaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose | Drug | 1 |
| Albaconazole 100mg capsules, then albaconazole 400mg tabletAlso: AlbaconazoleFour albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose | Drug | 2 |
Primary outcome
Bioavailability of albaconazole
Time frame: Blood samples taken predose and at 30 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (day 1 time points), 18 (day 2), 24 (day 2), hours post-dose and once a day on days 3-16
1 secondary outcome
Safety and tolerability of a single oral dose of 400mg albaconazole tablet
Time frame: ECGs and lab tests at screening, pre-dose, and 3 hours, and 16 days post-dose. Physical examination at screening, pre-dose and 16 days post-dose. Assessment of adverse events from consent to 16 days post-dose (second dosing period).
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 22 Jun 2017.
- Background: PubMed 23390369van Rossem K, Lowe JA. A Phase 1, randomized, open-label crossover study to evaluate the safety and pharmacokinetics of 400 mg albaconazole administered to healthy participants as a tablet formulation versus a capsule formulation. Clin Pharmacol. 2013;5:23-31. doi: 10.2147/CPAA.S39600. Epub 2013 Jan 30.
- Results for study 114563 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 Albaconazole tablet 400mg and Albaconazole 100mg capsules, then albaconazole 400mg tablet 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 17 inclusion and 26 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 22 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. 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?
Bioavailability of albaconazole (time frame: Blood samples taken predose and at 30 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (day 1 time points), 18 (day 2), 24 (day 2), hours post-dose and once a day on days 3-16). 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 NCT01039883, 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 22 Jun 2017.