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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin; Drug: Canagliflozin (JNJ-28431754)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756417

28431754NAP1004 (Other Identifier)

CR013636

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Metformin + canagliflozin (JNJ-28431754)

Experimental group

Description:

Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin.

Treatment:

Drug: Canagliflozin (JNJ-28431754)

Drug: Metformin