Multiple Dose Pharmacokinetics of Canagliflozin/Metformin... | NCT02039245

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

NCT02039245

Sponsor

Janssen Research & Development, LLC

Status

Completed

Last Update Posted

Apr 2, 2014Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

CANA/MET XR FDC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
28431754DIA1042	Other Identifier	Janssen Research & Development, LLC

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jan 15, 2014

First Submission Date that Met QC Criteria

Jan 15, 2014

First Posted Date

Jan 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2014

Last Update Posted Date

Apr 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CANA/MET XR FDC	Drug	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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Neptune City	New Jersey		United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided