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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.34 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Canagliflozin 300 mg once daily and 150 mg twice dailyDRUG

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.

Canagliflozin 100 mg once daily and 50 mg twice dailyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Plasma concentrations of canagliflozin

Time frame: Up to Day 5 after the last treatment

Plasma concentrations of glucose

Time frame: Up to Day 5 after the last treatment

Urinary glucose excretion (UGE)

Time frame: Up to Day 5 after the last treatment

Renal threshold of glucose (RTG)

Time frame: Up to Day 5 after the last treatment

Secondary Outcomes

The number and type of adverse events reported

Time frame: Up to 10 days after last dose (last dose is given on Day 8)

Changes in hematology laboratory parameters

Time frame: Up to 10 days after last dose (last dose is given on Day 8)

Changes in chemistry laboratory parameters

Time frame: Up to 10 days after last dose (last dose is given on Day 8)

Data from ClinicalTrials.gov

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