NCT02039245

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

January 15, 2014

Last Update Submit

April 1, 2014

Conditions

Healthy Volunteers

Keywords

Healthy VolunteersCanagliflozinMetforminINVOKANA®Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Percentage of participants with adverse events as a measure of safety and tolerability

    Screening, up to Day 10 of the follow-up

Study Arms (1)

Canagliflozin/Metformin XR

EXPERIMENTAL

Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg

Drug: CANA/MET XR FDC

Interventions

CANA/MET XR FDCDRUG

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)

Canagliflozin/Metformin XR

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 17, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

US(1)