A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01281579

Enrollment

Registered

2011-01-24

Start date

2011-01-31

Completion date

2011-04-30

Last updated

2012-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Pharmacodynamics, Canagliflozin

Brief summary

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

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.

Interventions

DRUGCanagliflozin 100 mg

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

DRUGCanagliflozin 50 mg

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

DRUGCanagliflozin 300 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of canagliflozin	At protocol-specified times up to Day 14
Urine concentrations of canagliflozin	At protocol-specified times up to Day 11
Plasma glucose concentrations	At protocol-specified times up to Day 11
Urine glucose concentrations	At protocol-specified times up to Day 11

Secondary

Measure	Time frame
The number and type of adverse events reported	Up to 10 days after last dose (last dose is given on Day 9)
Changes in hematology, chemistry and urinalysis parameters	Up to 10 days after last dose (last dose is given on Day 9)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026