A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.18 enrolled

Overview

The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.

This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MetforminDRUG

One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.

Canagliflozin (JNJ-28431754)DRUG

Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Volunteers must have a Body Mass Index (BMI \[weight (kg) / height (m)2\]) between 18.5 and 35 kg/m2, inclusive * Volunteers must be non-smokers or non-tobacco users Exclusion Criteria: \- History of or currently active illness that the Investigator considers to be clinically significant and should exclude the volunteer from the study or that could interfere with the interpretation of the study results

Locations (1)

Unnamed facility

Neptune City, New Jersey, United States

Outcomes

Primary Outcomes

The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754)

Cmax (a measure of the body's exposure to canagliflozin \[JNJ-28431754\]) will be compared before and after administration of a single dose of metformin.

Time frame: Up to Day 8

The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754)

AUC (a measure of the body's exposure to canagliflozin \[JNJ-28431754\]) will be compared before and after administration of a single dose of metformin.

Time frame: Up to Day 8

The maximum plasma concentration (Cmax) of metformin

Cmax (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).

Time frame: Up to Day 8

The area under the plasma concentration-time curve (AUC) for metformin

AUC (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).

Time frame: Up to Day 8

24-hour urine glucose excretion

24-hour urine glucose excretion will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.

Time frame: Up to Day 10

24-hour area under the serum glucose concentration-time curve

24-hour area under the serum glucose concentration-time curve will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.

Time frame: Up to Day 8

Secondary Outcomes

Data from ClinicalTrials.gov

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