A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

Janssen Research & Development, LLC15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Treatment A: Canagliflozin 100 mgDRUG

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

Treatment B: Canagliflozin 300 mgDRUG

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

Treatment C: PlaceboOTHER

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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