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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014