Healthy
Conditions
Keywords
Healthy, Canagliflozin (JNJ-28431754), Metformin, Pharmacokinetics, Pharmacodynamics
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.
Interventions
DRUGMetformin
One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.
Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of metformin | Up to Day 8 | 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 maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754) | Up to Day 8 | 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) | Up to Day 8 | 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. |
| 24-hour area under the serum glucose concentration-time curve | Up to Day 8 | 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. |
| The area under the plasma concentration-time curve (AUC) for metformin | Up to Day 8 | 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 | Up to Day 10 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to 18 days |
Countries
United States
Outcome results
None listed