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

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ClinicalTrials.gov Identifier: NCT01759576
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

December 24, 2012
January 3, 2013
May 29, 2013
March 2008
November 2008   (Final data collection date for primary outcome measure)
  • Plasma concentrations of canagliflozin (JNJ-28431754) in varying degrees of kidney function [ Time Frame: Up to Day 6 ]
    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.
  • Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function [ Time Frame: Day -1 (Baseline) to Day 3 ]
    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.
  • Plasma concentrations of canagliflozin (JNJ-28431754) metabolites in varying degrees of kidney function [ Time Frame: Up to Day 6 ]
    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.
Same as current
Complete list of historical versions of study NCT01759576 on ClinicalTrials.gov Archive Site
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A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function
An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function
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).
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Renal Insufficiency
  • Healthy
Drug: Canagliflozin (JNJ-28431754)
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).
Other Name: JNJ-28431754
  • Experimental: Group 1 (normal kidney function)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
    Intervention: Drug: Canagliflozin (JNJ-28431754)
  • Experimental: Group 2 (mild kidney impairment)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
    Intervention: Drug: Canagliflozin (JNJ-28431754)
  • Experimental: Group 3 (moderate kidney impairment)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
    Intervention: Drug: Canagliflozin (JNJ-28431754)
  • Experimental: Group 4 (severe kidney impairment)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
    Intervention: Drug: Canagliflozin (JNJ-28431754)
  • Experimental: Group 5 (hemodialysis)
    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.
    Intervention: Drug: Canagliflozin (JNJ-28431754)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01759576
CR014761
28431754DIA1003 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
No
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP