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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02039245
First received: January 15, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: CANA/MET XR FDC
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets [ Time Frame: Day 1, Day 7 ] [ Designated as safety issue: No ]
    Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

  • Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets [ Time Frame: Day 1, Day 7 ] [ Designated as safety issue: No ]
    Plasma concentrations of metformin are used to evaluate how long it stays in the body.


Secondary Outcome Measures:
  • Percentage of participants with adverse events as a measure of safety and tolerability [ Time Frame: Screening, up to Day 10 of the follow-up ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2014
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039245

Locations
United States, New Jersey
Neptune, New Jersey, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02039245     History of Changes
Other Study ID Numbers: CR103255, 28431754DIA1042
Study First Received: January 15, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy Volunteers
Canagliflozin
Metformin
INVOKANA®
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014