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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1010 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on electrocardiogram results (recordings of the electrical activity of the heart) in healthy volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4 times higher [1,200 mg] than the anticipated therapeutic dose of 300 mg). The safety and tolerability of canagliflozin will also be assessed.
This study will be a randomized (the treatment is assigned by chance), single-center, double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), double-dummy (a technique for retaining the blinded nature of the study when the treatments do not look identical), placebo-controlled (one of the treatments is inactive), positive-controlled (one of the treatments has a known potential effect on electrocardiogram results), four-way cross-over study (all volunteers will receive each of the 4 treatments but in a different order) to assess the effect of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) on electrocardiogram results in healthy volunteers. The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end-of study (or follow-up) phase. Volunteers will be assigned to 1 of 4 treatment sequence groups (ADBC, DABC, BCDA, or CDAB). The treatment sequence will be decided by randomization. Treatment A will be a single dose of 300 mg of canagliflozin. Treatment B will be a single dose of 1,200 mg of canagliflozin. Treatment C will be a single dose of placebo (inactive medication). Treatment D will be a single dose of 400 mg of moxifloxacin (an antibiotic with known potential to affect electrocardiogram results). Each treatment will be given during a treatment period of 2 days duration; each treatment period will be separated by a washout period (when no medication is given) of 10 to 14 days. Each volunteer will participate in the study for approximately 61 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ADBC) | Experimental | Each volunteer will receive Treatment A on Day 1 of Treatment Period 1, followed by Treatment D on Day 1 of Treatment Period 2, followed by Teatment B on Day 1 of Treatment Period 3, and followed by Treatment C on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period. |
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| Sequence 2 (BACD) | Experimental | Each volunteer will receive Treatment B on Day 1 of Treatment Period 1, followed by Treatment A on Day 1 of Treatment Period 2, followed by Treatment C on Day 1 of Treatment Period 3, and followed by Treatment D on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period. |
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| Sequence 3 (CBDA) | Experimental | Each volunteer will receive Treatment C on Day 1 of Treatment Period 1, followed by Treatment B on Day 1 of Treatment Period 2, followed by Treatment D on Day 1 of Treatment Period 3, and followed by Treatment A on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period. |
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| Sequence 4 (DCAB) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin (JNJ-28431754) | Drug | One 300 mg dose of canagliflozin (JNJ-28431754) (comprising one 100 mg over-encapsulated tablet and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Day 1 of Treatment A. One 1,200 mg dose of canagliflozin (comprising six 200 mg over-encapsulated tablets) taken orally on Day 1 of Treatment B. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTc intervals | QT intervals (assessment of the electrical activity of the heart) will be measured from 12-lead electrocardiogram (ECG) readings and will be corrected for heart rate. The corrected QT intervals (QTc) obtained following single doses of 300 mg canagliflozin (JNJ-28431754), 1,200 mg canagliflozin, and 400 mg moxifloxacin, will be compared with QTc intervals obtained following dosing with placebo. | Day 1 (Predose) up to Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of volunteers with adverse events | Adverse events will be used as a measure of safety and tolerability. | Up to 61 days |
| Plasma concentrations of canagliflozin (JNJ-28431754) | Plasma concentrations of canagliflozin (JNJ-28431754), following the administration of a single 300 mg dose and a single 1,200 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug). |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Label | URL |
|---|---|
| A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Four-Way Crossover Study Evaluating Electrocardiogram Intervals in Healthy Adults Receiving a Single, Oral Dose of JNJ-28431754 at Therapeutic and Supra-Therapeutic Doses | View source |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Each volunteer will receive Treatment D on Day 1 of Treatment Period 1, followed by Treatment C on Day 1 of Treatment Period 2, followed by Treatment A on Day 1 of Treatment Period 3, and followed by Treatment B on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period. |
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| Placebo | Drug | Four over-encapsulated matching placebo tablets taken orally (by mouth) on Day 1 of Treatment A. Six over-encapsulated matching placebo tablets taken orally on Day 1 of Treatment C. Five encapsulated matching placebo tablets taken orally on Day 1 of Treatment D. |
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| Moxifloxacin | Drug | One 400 mg over-encapsulated tablet of moxifloxacin taken orally (by mouth) on Day 1 of Treatment D. |
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| Up to Day 2 |
| QRS intervals obtained from 12-lead electrocardiogram (ECG) readings | QRS intervals will be obtained from 12-lead electrocardiogram (ECG) readings following a single 300 mg dose and a single 1,200 mg dose of canagliflozin (JNJ-28431754). | Up to Day 2 |
| PR intervals obtained from 12-lead electrocardiogram (ECG) readings | PR intervals will be obtained from 12-lead electrocardiogram (ECG) readings following a single 300 mg dose and a single 1,200 mg dose of canagliflozin (JNJ-28431754). | Up to Day 2 |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |