A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed. |
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Condition | Healthy |
Intervention | Drug: Metformin Drug: Canagliflozin (JNJ-28431754) |
Phase | Phase 1 |
Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier | NCT01756417 |
First Received | December 20, 2012 |
Last Updated | February 26, 2013 |
Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | December 20, 2012 |
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Last Updated Date | February 26, 2013 |
Start Date | October 2007 |
Estimated Primary Completion Date | November 2007 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | The number of volunteers with adverse events as a measure of safety and tolerability [Time Frame: up to 18 days] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers |
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Official Title | An Open-Label, Fixed Sequence, Single and Multiple Dose Study in Male and Female Subjects to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Metformin and JNJ-28431754 |
Brief Summary | The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed. |
Detailed Description | This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days. |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy |
Intervention | Drug: Metformin One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8. Drug: Canagliflozin (JNJ-28431754) Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8. Other Names: JNJ-28431754 |
Study Arm (s) | Experimental: Metformin + canagliflozin (JNJ-28431754) Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin. |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 18 |
Estimated Completion Date | November 2007 |
Estimated Primary Completion Date | November 2007 |
Eligibility Criteria | Inclusion Criteria: - Volunteers must have a Body Mass Index (BMI [weight (kg) / height (m)2]) between 18.5 and 35 kg/m2, inclusive - Volunteers must be non-smokers or non-tobacco users Exclusion Criteria: - History of or currently active illness that the Investigator considers to be clinically significant and should exclude the volunteer from the study or that could interfere with the interpretation of the study results |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01756417 |
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Other Study ID Numbers | CR013636 |
Has Data Monitoring Committee | No |
Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Collaborators | Not Provided |
Investigators | Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Verification Date | February 2013 |