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CANA/MET

Phase 1

Healthy Volunteers | Small molecule | Other |Johnson & Johnson|Last Updated: Jul 14, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

CANA/MET · 2 trials · 1 indication

Phase 1 2
NCT02039245Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose CombinationHealthy Volunteers
COMPLETED12 Analytics
NCT02039258Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With FoodHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets
Day 1, Day 7

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
Day 1, Day 7

Plasma concentrations of metformin are used to evaluate how long it stays in the body.

Plasma concentration of canagliflozin following the single dose of CANA/MET XR FDC after fed and fasted conditions
Predose, (before tablet intake) up to 72 hours afterdose

Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

Plasma concentration of metformin following the single dose of CANA/MET XR FDC after fed and fasted conditions
Predose, up to 72 hours afterdose

Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.

Secondary Endpoints

Percentage of participants with adverse events as a measure of safety and tolerability
Screening, up to Day 10 of the follow-up
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Canagliflozin/Metformin XREXPERIMENTALEach patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg
Sequence ABEXPERIMENTALA single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fasted conditions (treatment A) followed by the same single dose under fed conditions (treatment B).
Sequence BAEXPERIMENTALA single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fed conditions (treatment B) followed by the same single dose under fasted conditions (treatment A).

Interventions

NameTypeDescription
CANA/MET XR FDCDRUGEach 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)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about CANA/MET

What is CANA/MET?

CANA/MET is an investigational fixed-dose combination of canagliflozin and metformin, being developed by Johnson & Johnson (JNJ). It is a small molecule studied in healthy volunteers to evaluate the pharmacokinetics of the combination, including multiple-dose exposure and the effect of food on absorption.

Who makes CANA/MET?

CANA/MET is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting Phase 1 clinical trials to assess the pharmacokinetics of this fixed-dose combination of canagliflozin and metformin in healthy volunteers.

What phase is CANA/MET in?

CANA/MET is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is CANA/MET in?

CANA/MET has completed two Phase 1 trials: NCT02039245, a multiple-dose pharmacokinetic study of canagliflozin/metformin 150/1,000 mg fixed-dose combination, and NCT02039258, a pharmacokinetic study of the combination coadministered with food. Both enrolled healthy volunteers in the United States.

Is CANA/MET the same as canagliflozin/metformin?

CANA/MET is a fixed-dose combination of canagliflozin and metformin, two established drugs combined into a single tablet. The clinical trials evaluate the pharmacokinetics of this specific combination product, which is distinct from taking the two drugs separately.