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

NCT01759576 | Completed Phase 1

• 2 other identifiers: CR01476128431754DIA1003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Renal Insufficiency; Healthy

Keywords

Renal Insufficiency; Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Dialysis

Outcome Measures

Primary Outcomes (3)

• Plasma concentrations of canagliflozin (JNJ-28431754) in varying degrees of kidney function

  Plasma concentrations of canagliflozin (JNJ-28431754) following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug) in varying degrees of kidney function.

  Up to Day 6

• Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function

  Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body) in varying degrees of kidney function.

  Day -1 (Baseline) to Day 3

• Plasma concentrations of canagliflozin (JNJ-28431754) metabolites in varying degrees of kidney function

  Plasma concentrations of canagliflozin (JNJ-28431754) metabolites following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin metabolites (measurements describing how the body affects the metabolites) in varying degrees of kidney function.

  Up to Day 6

Study Arms (5)

Group 1 (normal kidney function)

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Group 2 (mild kidney impairment)

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Group 3 (moderate kidney impairment)

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Group 4 (severe kidney impairment)

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Group 5 (hemodialysis)

EXPERIMENTAL

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.

Drug: Canagliflozin (JNJ-28431754)

Interventions

Canagliflozin (JNJ-28431754) DRUG

Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).

Also known as: JNJ-28431754

Group 1 (normal kidney function); Group 2 (mild kidney impairment); Group 3 (moderate kidney impairment); Group 4 (severe kidney impairment); Group 5 (hemodialysis)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (3)

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Related Publications (1)

• Devineni D, Curtin CR, Marbury TC, Smith W, Vaccaro N, Wexler D, Vandebosch A, Rusch S, Stieltjes H, Wajs E. Effect of hepatic or renal impairment on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor. Clin Ther. 2015 Mar 1;37(3):610-628.e4. doi: 10.1016/j.clinthera.2014.12.013. Epub 2015 Feb 3.

  PMID: 25659911 DERIVED

Related Links

• An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 3, 2013
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

US (3)