A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

August 16, 2012 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-Label, Single-Dose, Randomized, 3-Period, Crossover Study to Evaluate the Pharmacokinetic Dose Proportionality of Canagliflozin of 50, 100, and 300 mg Under Fasted Conditions in Healthy Subjects

The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.

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 is an open-label study where healthy volunteers will know the name and dose of assigned treatment and will be randomly assigned to take a single oral (by mouth) dose of canagliflozin sequentially in each of 3 treament periods where the dose in each treatment period will be different (referred to as a 3-period crossover study) to evaluate the pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300 mg (Treatment C) during the study; a different dose will be taken in each treatment period. Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to 14-day washout period between Day 1 of each treatment period. Volunteers will fast (go without food) for at least 10 hours before and up to at least 4 hours after taking study drug.

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.
24

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:

  • Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

Exclusion Criteria:

  • History of or current medical illness deemed clinically significant by the Investigator (study physician)

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

  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: 001
Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
Drug: Canagliflozin, 50 mg
Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
Drug: Canagliflozin, 300 mg
Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
Drug: Canagliflozin, 100 mg
Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.

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
Time Frame
Plasma concentrations of canagliflozin
Time Frame: For up to 12 days (4 days during treatment periods 1, 2, and 3)
For up to 12 days (4 days during treatment periods 1, 2, and 3)

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
Time Frame
Adverse events
Time Frame: Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3)
Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3)
Clinical laboratory tests
Time Frame: Up to approximately 42 days
Up to approximately 42 days
Physical examinations
Time Frame: Up to approximately 42 days
Up to approximately 42 days
12-lead electrocardiograms (ECGs)
Time Frame: Up to approximately 42 days
Up to approximately 42 days
Vital signs
Time Frame: Up to approximately 42 days
Up to approximately 42 days

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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.
May 1, 2011

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, 2011

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, 2011

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).
April 21, 2011

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.
April 21, 2011

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.
April 22, 2011

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.
August 17, 2012

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.
August 16, 2012

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.
August 1, 2012

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.
  • CR018277
  • 28431754DIA1015
  • 2010-023251-28

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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