HealthyPhase 1NCT00935363
Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK)
A Phase 1 study testing glyburide, glyburide + fluconazole and glyburide + rifampin in people with Healthy, run by University of California, San Francisco.
Trial summary
The purpose of this study is to investigate if the drugs rifampin and fluconazole when given together increase the concentrations in the body of the oral diabetes medication glyburide. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- glyburide, glyburide + fluconazole and glyburide + rifampin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Apr 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations;
- BMI between 18.5 - 30 kg/m2;
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
- Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
- Be able to provide written informed consent and comply with requirements of the study;
- Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
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- Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
- Fast from food and beverages at least 8 hours prior to medication dosing;
- Be able to read, speak and understand English
Who cannot join
- Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
- Subjects with known allergy to glyburide and/or rifampin and/or fluconazole;
- Subjects who are not homozygous for CYP2C9 *1 (known poor metabolizers);
- Subjects with liver failure or LFTs >2x upper limit of normal;
- Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician;
- Subjects with Hct <30 mg/dL;
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- Subjects who smoke tobacco;
- Subjects with ongoing alcohol or illegal drug use;
- Subjects who are pregnant, lactating or attempting to conceive;
- Subjects unable to maintain adequate birth control during the study;
- Subjects unable to follow protocol instructions or protocol criteria.
About this study
The purpose of this study is to investigate if the drugs rifampin and fluconazole when given together increase the concentrations in the body of the oral diabetes medication glyburide.
Read the detailed description
The purpose of this study is to find out if a drug interaction occurs when glyburide is taken with rifampin and fluconazole. Glyburide is an oral drug commonly used to lower blood glucose levels in diabetic patients. Rifampin is an antibiotic used to treat tuberculosis and a variety of other infections caused by certain germs called bacteria. Both drugs affect a protein found in your liver cells called organic anion transporting polypeptides (OATPs). This protein regulates drugs getting into and out of your body. Fluconazole is commonly used to treat fungal infections like candidiasis, urinary tract infections and a variety of other infections caused by fungi. It interacts with glyburide by affecting your body's ability to breakdown glyburide. Since both rifampin and fluconazole play a role in the way glyburide enters and remains active in the body, we want to find out what effect taking the three drugs together has on the level of glyburide in the blood.
- Conditions
- Healthy
- Being tested
- glyburide, glyburide + fluconazole, glyburide + rifampin, glyburide + fluconazole + rifampin
- Keywords
- glyburide, pharmacokinetics, pharmacodynamics, drug interaction, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glyburideDrug
single oral dose
glyburide + fluconazoleDrug
single dose oral glyburide single dose iv fluconazole
glyburide + rifampinDrug
single dose oral glyburide single dose iv rifampin
glyburide + fluconazole + rifampinDrug
single dose oral glyburide single dose iv fluconazole single dose iv rifampin
| Study group | Role | What they receive |
|---|---|---|
| glyburide + fluconazole | Experimental | Not described Receives: Drug: glyburide + fluconazole |
| glyburide + rifampin | Experimental | Not described Receives: Drug: glyburide + rifampin |
| glyburide | Active comparator | Not described Receives: Drug: glyburide |
| glyburide + fluconazole + rifampin | Experimental | Not described Receives: Drug: glyburide + fluconazole + rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Plasma Levels
Measured: 24 hours
Secondary outcomes (1)
Blood sugar levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
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.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935363
- Sponsor's protocol ID
- GlyburideOATP2C9
- Status last verified
- Jan 2015
- First submitted
- 7 Jul 2009
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK)
- ClinicalTrials.gov ID
- NCT00935363
- Acronym / sponsor ID
- GlyburideOATP2C9
- Conditions
- Healthy
- Keywords
- glyburide, pharmacokinetics, pharmacodynamics, drug interaction, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 9 Jul 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 investigate if the drugs rifampin and fluconazole when given together increase the concentrations in the body of the oral diabetes medication glyburide.
Detailed description
The purpose of this study is to find out if a drug interaction occurs when glyburide is taken with rifampin and fluconazole. Glyburide is an oral drug commonly used to lower blood glucose levels in diabetic patients. Rifampin is an antibiotic used to treat tuberculosis and a variety of other infections caused by certain germs called bacteria. Both drugs affect a protein found in your liver cells called organic anion transporting polypeptides (OATPs). This protein regulates drugs getting into and out of your body. Fluconazole is commonly used to treat fungal infections like candidiasis, urinary tract infections and a variety of other infections caused by fungi. It interacts with glyburide by affecting your body's ability to breakdown glyburide. Since both rifampin and fluconazole play a role in the way glyburide enters and remains active in the body, we want to find out what effect taking the three drugs together has on the level of glyburide in the blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| glyburide + fluconazole | Experimental | Drug: glyburide + fluconazole |
| glyburide + rifampin | Experimental | Drug: glyburide + rifampin |
| glyburide | Active comparator | Drug: glyburide |
| glyburide + fluconazole + rifampin | Experimental | Drug: glyburide + fluconazole + rifampin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations;
- BMI between 18.5 - 30 kg/m2;
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
- Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
- Be able to provide written informed consent and comply with requirements of the study;
Key exclusion criteria (11 listed)
- Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
- Subjects with known allergy to glyburide and/or rifampin and/or fluconazole;
- Subjects who are not homozygous for CYP2C9 *1 (known poor metabolizers);
- Subjects with liver failure or LFTs >2x upper limit of normal;
- Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician;
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 |
|---|---|---|
| glyburidesingle oral dose | Drug | glyburide |
| glyburide + fluconazolesingle dose oral glyburide single dose iv fluconazole | Drug | glyburide + fluconazole |
| glyburide + rifampinsingle dose oral glyburide single dose iv rifampin | Drug | glyburide + rifampin |
| glyburide + fluconazole + rifampinsingle dose oral glyburide single dose iv fluconazole single dose iv rifampin | Drug | glyburide + fluconazole + rifampin |
Primary outcome
Drug Plasma Levels
Time frame: 24 hours
1 secondary outcome
Blood sugar levels
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing glyburide, glyburide + fluconazole and glyburide + rifampin in people with Healthy, run by University of California, San Francisco.
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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Drug Plasma Levels (time frame: 24 hours). 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 14 Jan 2015.