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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1026 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.
This study will be a double-blind (neither the Investigator nor volunteer knows the assigned treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the study treatments is inactive), single-dose, 3-way cross over study (all volunteers will receive each of the 3 treatments but in a different order) in healthy Chinese volunteers. Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The treatment sequence will be decided by randomization. Treatment A will be a single oral (by mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each treatment will be given during a treatment period of 5 days duration; each treatment period will be separated by a washout period (a time period with no medication) of at least 10 days. Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Treatment A-B-C | Experimental | The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days. |
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| Sequence 2: Treatment B-C-A | Experimental | The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days. |
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| Sequence 3: Treatment C-A-B | Experimental | The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Canagliflozin 100 mg | Drug | Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose | Plasma concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug) for canagliflozin and its major metabolites. | Up to Day 4 |
| Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose | Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites. | Up to Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) | Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine. | Up to Day 2 |
| Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26048186 | Derived | Chen X, Hu P, Vaccaro N, Polidori D, Curtin CR, Stieltjes H, Sha S, Weiner S, Devineni D. Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects. Clin Ther. 2015 Jul 1;37(7):1483-1492.e1. doi: 10.1016/j.clinthera.2015.04.015. Epub 2015 Jun 3. |
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| Treatment B: Canagliflozin 300 mg | Drug | Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1. |
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| Treatment C: Placebo | Other | Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1. |
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UGE is equal to the amount of glucose excreted into the urine over defined time intervals. |
| Up to Day 2 |
| Mean plasma glucose concentration following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) | Up to Day 2 |