A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

February 18, 2013 updated by: Janssen Research & Development, LLC

A Double-Blind, Randomized, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of JNJ-28431754 (Canagliflozin) in Healthy Chinese Subjects

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a double-blind (neither the Investigator nor volunteer knows the assigned treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the study treatments is inactive), single-dose, 3-way cross over study (all volunteers will receive each of the 3 treatments but in a different order) in healthy Chinese volunteers. Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The treatment sequence will be decided by randomization. Treatment A will be a single oral (by mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each treatment will be given during a treatment period of 5 days duration; each treatment period will be separated by a washout period (a time period with no medication) of at least 10 days. Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus (T2DM).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteers must be non-smokers for at least 6 months before first study drug administration
  • Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day

Exclusion Criteria:

  • History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
  • Female volunteer is breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sequence 1: Treatment A-B-C
The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
Drug: Treatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Other Names:
  • JNJ-28431754
Drug: Treatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Other Names:
  • JNJ-28431754
Other: Treatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
EXPERIMENTAL: Sequence 2: Treatment B-C-A
The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
Drug: Treatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Other Names:
  • JNJ-28431754
Drug: Treatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Other Names:
  • JNJ-28431754
Other: Treatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
EXPERIMENTAL: Sequence 3: Treatment C-A-B
The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
Drug: Treatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Other Names:
  • JNJ-28431754
Drug: Treatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Other Names:
  • JNJ-28431754
Other: Treatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose
Time Frame: Up to Day 4
Plasma concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug) for canagliflozin and its major metabolites.
Up to Day 4
Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose
Time Frame: Up to Day 2
Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites.
Up to Day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)
Time Frame: Up to Day 2
Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.
Up to Day 2
Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)
Time Frame: Up to Day 2
UGE is equal to the amount of glucose excreted into the urine over defined time intervals.
Up to Day 2
Mean plasma glucose concentration following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)
Time Frame: Up to Day 2
Up to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100923
  • 28431754DIA1026 (OTHER: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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