HealthyPhase 1NCT00695071
Study to Assess Blood Levels of Itraconazole During a Two-Week Period
A Phase 1 study testing Itraconazole in people with Healthy, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.0 and 28.0 kg/m2
- Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
- Vital signs (blood pressure and heart rate) in supine position within the normal range
- Electrocardiogram (12 lead) considered as normal
- Non-smoker.
- Able to swallow pills
- If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol
Who cannot join
- Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
- History or presence of drug abuse or consumption of alcohol
- History of sensitivity or allergy to azoles or related drugs
- Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
- Unsuitable veins for repeated venipuncture.
- Clinically significant abnormal ECG
- Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Biomedical Research
Hackensack, New Jersey, 07601
About this study
Official title: Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition
The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.
- Conditions
- Healthy
- Being tested
- Itraconazole
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady State Plasma levels of Itraconazole
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695071
- Sponsor's protocol ID
- BT0300-108-USA
- Status last verified
- Sep 2011
- First submitted
- 9 Jun 2008
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition
- ClinicalTrials.gov ID
- NCT00695071
- Acronym / sponsor ID
- BT0300-108-USA
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Jun 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 objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI between 18.0 and 28.0 kg/m2
- Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
- Vital signs (blood pressure and heart rate) in supine position within the normal range
- Electrocardiogram (12 lead) considered as normal
- Non-smoker.
Key exclusion criteria (7 listed)
- Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
- History or presence of drug abuse or consumption of alcohol
- History of sensitivity or allergy to azoles or related drugs
- Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
- Unsuitable veins for repeated venipuncture.
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 |
|---|---|---|
| ItraconazoleOral | Drug | A |
Primary outcome
Steady State Plasma levels of Itraconazole
Time frame: 2 weeks
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 26 Sep 2011.
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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, MD 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 Itraconazole in people with Healthy, 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 7 inclusion and 7 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 26 Sep 2011. 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?
Steady State Plasma levels of Itraconazole (time frame: 2 weeks). 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 26 Sep 2011.