A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers

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

Overview

The purpose of the study is to investigate the potential interaction between multiple oral doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of canagliflozin and metformin in healthy adult volunteers. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. Canagliflozin will be administered orally (by mouth) as a single 300-mg tablet on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 1,000 mg tablets on Days 1 and 8. Both canagliflozin and metformin tablets will be taken with 8 ounces (240 mL) of water.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Canagliflozin/MetforminDRUG

Two 1000-mg tablets of metformin on Day 1 followed by one 300-mg tablet of canagliflozin once daily on Days 4 through 8, followed by two 1000-mg tablets of metformin and one 300-mg tablet of canagliflozin on Day 8.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive. Exclusion Criteria: * History of or current clinically significant medical illness as determined by the Investigator * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * Known allergy to canagliflozin or metformin or any of the excipients of the formulation of canagliflozin or metformin * Known allergy to heparin or history of heparin induced thrombocytopenia.

Outcomes

Primary Outcomes

Plasma concentrations of canagliflozin

Time frame: At protocol-specified times up to Day 11

Plasma concentrations of metformin

Time frame: At protocol-specified times up to Day 11)

Urine concentrations of metformin

Time frame: At protocol-specified times up to Day 10)

Plasma concentrations of glucose

Time frame: Up to Day 9

Urinary glucose excretion (UGE)

Time frame: Up to Day 11

Secondary Outcomes

The number and type of adverse events reported

Time frame: Up to Day 8

Data from ClinicalTrials.gov

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