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A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

NCT ID: NCT01281579

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.

Detailed Description

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This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.

Conditions

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Healthy

Keywords

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Pharmacokinetics Pharmacodynamics Canagliflozin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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001

Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9.

Group Type EXPERIMENTAL

Canagliflozin 50 mg

Intervention Type DRUG

Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.

002

Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9.

Group Type EXPERIMENTAL

Canagliflozin 100 mg

Intervention Type DRUG

Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.

003

Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9.

Group Type EXPERIMENTAL

Canagliflozin 300 mg

Intervention Type DRUG

Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.

Interventions

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Canagliflozin 100 mg

Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.

Intervention Type DRUG

Canagliflozin 50 mg

Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.

Intervention Type DRUG

Canagliflozin 300 mg

Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
* Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Countries

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Belgium

Other Identifiers

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28431754DIA1030

Identifier Type: -

Identifier Source: secondary_id

CR017695

Identifier Type: -

Identifier Source: org_study_id