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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1030 |
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The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.
This is an open-label (volunteers and study staff will know the name and dose of the treatment 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). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9. |
|
| 002 | Experimental | Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9. |
|
| 003 | Experimental | Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin 100 mg | Drug | Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of canagliflozin | At protocol-specified times up to Day 14 | |
| Urine concentrations of canagliflozin | At protocol-specified times up to Day 11 | |
| Plasma glucose concentrations | At protocol-specified times up to Day 11 | |
| Urine glucose concentrations | At protocol-specified times up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| The number and type of adverse events reported | Up to 10 days after last dose" (last dose is given on Day 9) | |
| Changes in hematology, chemistry and urinalysis parameters | Up to 10 days after last dose" (last dose is given on Day 9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Canagliflozin 50 mg |
| Drug |
Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9. |
|
| Canagliflozin 300 mg | Drug | Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9. |
|
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |