- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733108
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers
December 11, 2012 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label Drug-Drug Interaction Study in Healthy Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of Glyburide
The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of glyburide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days) to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and pharmacodynamics of glyburide (a blood glucose-lowering agent used to treat patients with diabetes).
The study will consist of 3 phases; a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase.
During the open-label treatment phase, each volunteer will receive a single 1.25 mg dose of glyburide on Day 1, followed by 200 mg canagliflozin once daily on Days 4 through 8. On Day 9 volunteers will receive both glyburide 1.25 mg and canagliflozin 200 mg.
Each volunteer will participate in the study for approximately 40 days.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteer must have a body mass index (BMI = weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg Exclusion Criteria:
- Volunteer has a history of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
- Volunteer has a fasting plasma glucose < 100 mg/dL (as measured by oral glucose tolerance test) and a 2-hour plasma glucose <= 140 mg/dL
- History of smoking or use of nicotine-containing substances within the previous 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Canagliflozin (JNJ-28431754) + glyburide
Each volunteer will receive a single dose of glyburide on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of glyburide in combination with a single dose of canagliflozin.
|
One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.
Other Names:
One 200 mg tablet taken orally (by mouth) on Days 4 through 9.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma concentrations of glyburide
Time Frame: Up to Day 12
|
Comparison of plasma concentrations of glyburide following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754).
This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.
|
Up to Day 12
|
Plasma concentrations of glyburide metabolites
Time Frame: Up to Day 12
|
Comparison of plasma concentrations of glyburide metabolites following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754).
This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.
|
Up to Day 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in plasma glucose concentrations
Time Frame: Day -1 (Baseline) up to Day 9
|
Plasma glucose concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes in plasma glucose) between glyburide and canagliflozin.
The area under the plasma glucose concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.
|
Day -1 (Baseline) up to Day 9
|
Change from baseline in plasma insulin concentrations
Time Frame: Day -1 (Baseline) up to Day 9
|
Plasma insulin concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes to plasma insulin) between glyburide and canagliflozin.
The area under the plasma insulin concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.
|
Day -1 (Baseline) up to Day 9
|
Change from baseline in plasma C-peptide concentrations
Time Frame: Day -1 (Baseline) up to Day 9
|
Plasma C-peptide is formed during the body's production of insulin.
Plasma C-peptide concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes to plasma C-peptide) between glyburide and canaglifloxin.
The area under the plasma C-peptide concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.
|
Day -1 (Baseline) up to Day 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
November 20, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (Estimate)
November 26, 2012
Study Record Updates
Last Update Posted (Estimate)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 11, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR014872
- 28431754DIA1004 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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