Healthy
Conditions
Keywords
Healthy, JNJ-28431754, Canagliflozin, Pharmacokinetics, Pharmacodynamics
Brief summary
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.
Detailed description
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).
Interventions
DRUGTreatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
DRUGTreatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
OTHERTreatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Volunteers must be non-smokers for at least 6 months before first study drug administration * Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day
Exclusion criteria
* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results * Female volunteer is breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose | Up to Day 4 | 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. |
| Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose | Up to Day 2 | Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) | Up to Day 2 | Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine. |
| Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) | Up to Day 2 | UGE is equal to the amount of glucose excreted into the urine over defined time intervals. |
| 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 | — |
Countries
China
Outcome results
None listed