- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748526
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers
July 15, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Single-Dose, Open-Label, Randomized, Two-Way, Cross-Over Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Healthy Indian Subjects
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of canagliflozin (JNJ-28431754) in healthy Indian volunteers.
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), randomized (the treatment is assigned by chance), single center, single dose, 2-way cross-over study (all volunteers switch from one treatment to another) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in healthy Indian volunteers.
The study will consist of 3 phases: a single screening phase, a baseline phase of 2 days per period, and an open-label treatment phase that includes 2 treatment periods (Periods 1 and 2).
During Period 1, volunteers will be randomly assigned to receive a single dose of either 200 mg (Treatment A) or 300 mg (Treatment B) of canagliflozin on Day 1.
During Period 2, volunteers will receive the dose of canagliflozin (Treatment A or B) that they did not receive during Period 1.
The duration of each treatment period will be 4 days and each treatment period will be separated by a 14 day washout period (when no medication is given).
Each volunteer will participate in the study for approximately 45 days.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ahmedabad, India
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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 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
- Volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 mL/min/1.73 m2 using the Modification of Diet in Renal Disease calculation
- Fasting blood glucose at screening must be less than 100 mg/dL and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dL
Exclusion Criteria:
- 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
- Female volunteer is breast-feeding
- Volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
Each volunteer will receive a single 200 mg dose of canagliflozin (JNJ-28431754) on Day 1.
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One 200 mg tablet taken orally (by mouth) on Day 1.
Other Names:
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Experimental: Treatment B
Each volunteer will receive a single 300 mg dose of canagliflozin (JNJ-28431754) on Day 1.
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One 300 mg tablet taken orally (by mouth) on Day 1.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma concentrations of canagliflozin JNJ-28431754)
Time Frame: Up to Day 4
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Plasma concentrations of canagliflozin (JNJ-28431754), following the administration of a single 200mg dose and a single 300 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
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Up to Day 4
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Urine concentrations of canagliflozin (JNJ-28431754)
Time Frame: Up to Day 4
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Urine concentrations of canagliflozin (JNJ-28431754), following the administration of a single 200mg dose and a single 300 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
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Up to Day 4
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Change from baseline in 24-hour urine glucose excretion
Time Frame: Day -1 (Baseline) up to Day 3
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Change from baseline in 24-hour urine glucose excretion following the administration of a single 200 mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body).
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Day -1 (Baseline) up to Day 3
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Change from baseline in the area under the plasma glucose concentration-time curve (AUC)
Time Frame: Day -1 (Baseline) and 4 hours post-dose
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Change from baseline in the area under the plasma glucose concentration-time curve (AUC) (a measure of the body's exposure to glucose) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).
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Day -1 (Baseline) and 4 hours post-dose
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Change from baseline in the area under the plasma insulin concentration-time curve (AUC)
Time Frame: Day -1 (Baseline) and 4 hours post-dose
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Change from baseline in the area under the plasma insulin concentration-time curve (AUC) (a measure of the body's exposure to insulin) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).
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Day -1 (Baseline) and 4 hours post-dose
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Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC)
Time Frame: Day -1 (Baseline) and 4 hours post-dose
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Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC) (a measure of the body's exposure to C-peptide) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).
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Day -1 (Baseline) and 4 hours post-dose
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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
August 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
December 10, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (Estimate)
December 12, 2012
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 15, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR014986
- 28431754DIA1008 (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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