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A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01281579
First received: January 20, 2011
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

January 20, 2011
November 29, 2012
January 2011
April 2011   (final data collection date for primary outcome measure)
  • Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times up to Day 14 ] [ Designated as safety issue: No ]
  • Urine concentrations of canagliflozin [ Time Frame: At protocol-specified times up to Day 11 ] [ Designated as safety issue: No ]
  • Plasma glucose concentrations [ Time Frame: At protocol-specified times up to Day 11 ] [ Designated as safety issue: No ]
  • Urine glucose concentrations [ Time Frame: At protocol-specified times up to Day 11 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01281579 on ClinicalTrials.gov Archive Site
  • The number and type of adverse events reported [ Time Frame: Up to 10 days after last dose" (last dose is given on Day 9) ] [ Designated as safety issue: No ]
  • Changes in hematology, chemistry and urinalysis parameters [ Time Frame: Up to 10 days after last dose" (last dose is given on Day 9) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers
An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Canagliflozin 100 mg
    Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.
  • Drug: Canagliflozin 50 mg
    Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.
  • Drug: Canagliflozin 300 mg
    Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.
  • Experimental: 001
    Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9.
    Intervention: Drug: Canagliflozin 50 mg
  • Experimental: 002
    Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9.
    Intervention: Drug: Canagliflozin 100 mg
  • Experimental: 003
    Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9.
    Intervention: Drug: Canagliflozin 300 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01281579
CR017695, 28431754DIA1030
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.
November 2012

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