- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286103
A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers
March 12, 2012 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects
The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open-label (volunteers will know the names of treatments they are assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers.
Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).
Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth [PO] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.
Study Type
Interventional
Enrollment (Actual)
34
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
Exclusion Criteria:
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
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: 001
Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
|
Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
|
Experimental: 002
Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
|
Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentrations of canagliflozin
Time Frame: Up to Day 5 after the last treatment
|
Up to Day 5 after the last treatment
|
Plasma concentrations of glucose
Time Frame: Up to Day 5 after the last treatment
|
Up to Day 5 after the last treatment
|
Urinary glucose excretion (UGE)
Time Frame: Up to Day 5 after the last treatment
|
Up to Day 5 after the last treatment
|
Renal threshold of glucose (RTG)
Time Frame: Up to Day 5 after the last treatment
|
Up to Day 5 after the last treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number and type of adverse events reported
Time Frame: Up to 10 days after last dose (last dose is given on Day 8)
|
Up to 10 days after last dose (last dose is given on Day 8)
|
Changes in hematology laboratory parameters
Time Frame: Up to 10 days after last dose (last dose is given on Day 8)
|
Up to 10 days after last dose (last dose is given on Day 8)
|
Changes in chemistry laboratory parameters
Time Frame: Up to 10 days after last dose (last dose is given on Day 8)
|
Up to 10 days after last dose (last dose is given on Day 8)
|
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
January 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
January 13, 2011
First Submitted That Met QC Criteria
January 27, 2011
First Posted (Estimate)
January 31, 2011
Study Record Updates
Last Update Posted (Estimate)
March 13, 2012
Last Update Submitted That Met QC Criteria
March 12, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR017824
- 28431754DIA1032
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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