A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (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
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metformin Drug: Canagliflozin (JNJ-28431754) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754) [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]Cmax (a measure of the body's exposure to canagliflozin [JNJ-28431754]) will be compared before and after administration of a single dose of metformin.
- The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754) [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]AUC (a measure of the body's exposure to canagliflozin [JNJ-28431754]) will be compared before and after administration of a single dose of metformin.
- The maximum plasma concentration (Cmax) of metformin [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]Cmax (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).
- The area under the plasma concentration-time curve (AUC) for metformin [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]AUC (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).
- 24-hour urine glucose excretion [ Time Frame: Up to Day 10 ] [ Designated as safety issue: No ]24-hour urine glucose excretion will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.
- 24-hour area under the serum glucose concentration-time curve [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]24-hour area under the serum glucose concentration-time curve will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.
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 ]
| Enrollment: | 18 |
| Study Start Date: | October 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 Name: JNJ-28431754
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756417
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01756417 History of Changes |
| Other Study ID Numbers: | CR013636, 28431754NAP1004 |
| Study First Received: | December 20, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Healthy Canagliflozin (JNJ-28431754) Metformin Pharmacokinetics Pharmacodynamics |
Additional relevant MeSH terms:
|
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013