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WithdrawnNCT00935363Updated Jan 14, 2015

Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK)

A Phase 1 interventional study of glyburide and glyburide + fluconazole in Healthy, sponsored by University of California, San Francisco. Withdrawn. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy

Keywords

  • glyburide
  • pharmacokinetics
  • pharmacodynamics
  • drug interaction
  • Healthy Volunteers
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 261 completed or terminated interventional studies of FDA-regulated products, 195 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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;
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    glyburide + fluconazole

    Drug: glyburide + fluconazole

  • Experimental
    glyburide + rifampin

    Drug: glyburide + rifampin

  • Active comparator
    glyburide

    Drug: glyburide

  • Experimental
    glyburide + fluconazole + rifampin

    Drug: glyburide + fluconazole + rifampin

Interventions

  • Drugglyburide

    single oral dose

  • Drugglyburide + fluconazole

    single dose oral glyburide single dose iv fluconazole

  • Drugglyburide + rifampin

    single dose oral glyburide single dose iv rifampin

  • Drugglyburide + fluconazole + rifampin

    single dose oral glyburide single dose iv fluconazole single dose iv rifampin

06

What researchers measure

Primary outcomes

  1. Drug Plasma Levels

    Time frame: 24 hours

Secondary outcomes

  1. Blood sugar levels

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00935363
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Jul 9, 2009
Start date
Feb 2010
Primary completion
Mar 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Jan 14, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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