A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Canagliflozin 300 mg; Drug: Canagliflozin 50 mg; Drug: Canagliflozin 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01281579

28431754DIA1030

CR017695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 3 patient groups

001

Experimental group

Description:

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

Treatment:

Drug: Canagliflozin 50 mg

002

Experimental group

Description:

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

Treatment:

Drug: Canagliflozin 100 mg

003

Experimental group

Description:

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

Treatment:

Drug: Canagliflozin 300 mg