A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01286103

Enrollment

Registered

2011-01-31

Start date

2011-01-31

Completion date

2011-05-31

Last updated

2012-03-13

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

Conditions

Healthy

Keywords

Canagliflozin, Pharmacokinetics, Pharmacodynamics

Brief summary

The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers

Detailed description

This is an open-label (volunteers will know the names of treatments they are 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). Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth \[PO\] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.

Interventions

DRUGCanagliflozin 100 mg once daily and 50 mg twice daily

Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.

DRUGCanagliflozin 300 mg once daily and 150 mg twice daily

Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 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 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	Up to Day 5 after the last treatment
Plasma concentrations of glucose	Up to Day 5 after the last treatment
Urinary glucose excretion (UGE)	Up to Day 5 after the last treatment
Renal threshold of glucose (RTG)	Up to Day 5 after the last treatment

Secondary

Measure	Time frame
Changes in hematology laboratory parameters	Up to 10 days after last dose (last dose is given on Day 8)
Changes in chemistry laboratory parameters	Up to 10 days after last dose (last dose is given on Day 8)
The number and type of adverse events reported	Up to 10 days after last dose (last dose is given on Day 8)

Outcome results

None listed

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