A Phase 1 interventional study of Treatment A: Canagliflozin 100 mg and Treatment B: Canagliflozin 300 mg in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-20.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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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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.
Drug: Treatment A: Canagliflozin 100 mg · Drug: Treatment B: Canagliflozin 300 mg · Other: Treatment C: Placebo
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.
Drug: Treatment A: Canagliflozin 100 mg · Drug: Treatment B: Canagliflozin 300 mg · Other: Treatment C: Placebo
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.
Drug: Treatment A: Canagliflozin 100 mg · Drug: Treatment B: Canagliflozin 300 mg · Other: Treatment C: Placebo
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Also known as: JNJ-28431754
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Also known as: JNJ-28431754
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
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.
Time frame: 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.
Time frame: Up to Day 2
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.
Time frame: 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)
UGE is equal to the amount of glucose excreted into the urine over defined time intervals.
Time frame: 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)
Time frame: Up to Day 2
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC