Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

An Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics of Canagliflozin (JNJ-28431754) and Metformin Following Once-Daily Administration of 2 Canagliflozin/Metformin XR (150/1,000-mg) Fixed Dose Combination Tablets in Healthy Subjects

The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CANA/MET XR FDC

Detailed Description

This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Neptune, New Jersey, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign an informed consent document indicating they understand the purpose of the study and procedures
• Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
• Must have a body weight of not less than 50 kg
• Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
• Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

• History of or current clinically significant medical illness
• Use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements)
• Known allergy to canagliflozin or metformin or any of the excipients of the formulation
• Known allergy to heparin or history of heparin induced thrombocytopenia
• History of smoking or use of nicotine-containing substances within the previous 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canagliflozin/Metformin XR; Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg	Drug: CANA/MET XR FDC; Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets	Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.	Day 1, Day 7
Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets	Plasma concentrations of metformin are used to evaluate how long it stays in the body.	Day 1, Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with adverse events as a measure of safety and tolerability	Screening, up to Day 10 of the follow-up

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Estimate): April 2, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Metformin; Healthy Volunteers; Canagliflozin; Type 2 Diabetes Mellitus; INVOKANA®
• Other Study ID Numbers: CR103255; 28431754DIA1042 (Other Identifier: Janssen Research & Development, LLC)