A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Insufficiency

Treatments: Drug: Canagliflozin (JNJ-28431754)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01759576

CR014761

28431754DIA1003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying degrees of kidney impairment (including volunteers with end-stage renal disease requiring hemodialysis).

Full description

This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single-dose, multicenter (the study will be conducted at more than one center), parallel-group study (each group of volunteers will be treated at the same time) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in volunteers with varying degrees of kidney function. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. Volunteers will be assigned to 1 of 5 groups (depending on kidney function): group 1 will have normal kidney function; group 2 will have mild kidney impairment; group 3 will have moderate kidney impairment; group 4 will have severe kidney impairment; and group 5 will comprise volunteers requiring hemodialysis. Volunteers in groups 1 through 4 will receive a single dose of canagliflozin on Day 1. Volunteers in group 5 will receive a single dose of canagliflozin following dialysis and then, approximately 10 days later, they will receive a second dose before dialysis. Volunteers in groups 1 through 4 will participate in the study for 27 days. Volunteers in group 5 will participate in the study for 40 days.

Enrollment: 40 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 20 and 40 kg/m2 (inclusive), and body weight not less than 50 kg
• Volunteers must smoke no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

Exclusion criteria

• History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
• Volunteers with end stage renal disease receiving dialysis treatment other than intermittent hemodialysis
• Volunteers with end stage renal disease who have received a renal transplantation within 1 year before screening
• Volunteers with end stage renal disease diagnosed with renal carcinoma within 1 year before screening
• Volunteers with end stage renal disease receiving immunosuppressive medications, including steroids

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Group 1 (normal kidney function)

Experimental group

Description:

Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1

Treatment:

Drug: Canagliflozin (JNJ-28431754)

Group 2 (mild kidney impairment)

Experimental group

Description:

Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1

Treatment:

Drug: Canagliflozin (JNJ-28431754)

Group 3 (moderate kidney impairment)

Experimental group

Description:

Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1

Treatment:

Drug: Canagliflozin (JNJ-28431754)

Group 4 (severe kidney impairment)

Experimental group

Description:

Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1

Treatment:

Drug: Canagliflozin (JNJ-28431754)

Group 5 (hemodialysis)

Experimental group

Description:

Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 following completion of hemodialysis. Approximately 10 days later, each volunteer will receive another single dose of canagliflozin before hemodialysis begins.

Treatment:

Drug: Canagliflozin (JNJ-28431754)