A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.
ConditionHealthy
InterventionDrug: Metformin
Drug: Canagliflozin (JNJ-28431754)
PhasePhase 1
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible PartyJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov IdentifierNCT01756417
First ReceivedDecember 20, 2012
Last UpdatedFebruary 26, 2013
Last verifiedFebruary 2013

Tracking Information[ + expand ][ + ]

First Received DateDecember 20, 2012
Last Updated DateFebruary 26, 2013
Start DateOctober 2007
Estimated Primary Completion DateNovember 2007
Current Primary Outcome Measures
  • The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754) [Time Frame: Up to Day 8] [Designated as safety issue: No]Cmax (a measure of the body's exposure to canagliflozin [JNJ-28431754]) will be compared before and after administration of a single dose of metformin.
  • The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754) [Time Frame: Up to Day 8] [Designated as safety issue: No]AUC (a measure of the body's exposure to canagliflozin [JNJ-28431754]) will be compared before and after administration of a single dose of metformin.
  • The maximum plasma concentration (Cmax) of metformin [Time Frame: Up to Day 8] [Designated as safety issue: No]Cmax (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).
  • The area under the plasma concentration-time curve (AUC) for metformin [Time Frame: Up to Day 8] [Designated as safety issue: No]AUC (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).
  • 24-hour urine glucose excretion [Time Frame: Up to Day 10] [Designated as safety issue: No]24-hour urine glucose excretion will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.
  • 24-hour area under the serum glucose concentration-time curve [Time Frame: Up to Day 8] [Designated as safety issue: No]24-hour area under the serum glucose concentration-time curve will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.
Current Secondary Outcome MeasuresThe number of volunteers with adverse events as a measure of safety and tolerability [Time Frame: up to 18 days] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers
Official TitleAn Open-Label, Fixed Sequence, Single and Multiple Dose Study in Male and Female Subjects to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Metformin and JNJ-28431754
Brief Summary
The purpose of this study is to investigate whether there is a drug-drug interaction between
multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety
and tolerability of canagliflozin will also be assessed.
Detailed Description
This study is an open-label (all volunteers and study staff know the identity of the
assigned treatment), fixed sequence (all volunteers receive the same medication on the same
days), single and multiple-dose study to determine how metformin (a blood glucose-lowering
agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body
affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of
canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes
mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of
metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an
open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will
participate in the study for approximately 39 days.
Study TypeInterventional
Study PhasePhase 1
Study DesignEndpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: Metformin
One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.
Drug: Canagliflozin (JNJ-28431754)
Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.
Other Names:
JNJ-28431754
Study Arm (s)Experimental: Metformin + canagliflozin (JNJ-28431754)
Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment18
Estimated Completion DateNovember 2007
Estimated Primary Completion DateNovember 2007
Eligibility Criteria
Inclusion Criteria:

- Volunteers must have a Body Mass Index (BMI [weight (kg) / height (m)2]) between 18.5
and 35 kg/m2, inclusive

- Volunteers must be non-smokers or non-tobacco users

Exclusion Criteria:

- History of or currently active illness that the Investigator considers to be clinically
significant and should exclude the volunteer from the study or that could interfere with
the interpretation of the study results
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01756417
Other Study ID NumbersCR013636
Has Data Monitoring CommitteeNo
Information Provided ByJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
CollaboratorsNot Provided
Investigators Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification DateFebruary 2013