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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
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Canagliflozin 100 mg
Drug: Canagliflozin 50 mg
Drug: Canagliflozin 300 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Canagliflozin 50 mg Tablets oral 50-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.
Experimental: 002
Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9.
 Drug: Canagliflozin 100 mg
Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.
Experimental: 003
Canagliflozin 300 mg Tablets oral 300-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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281579

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01281579     History of Changes
Other Study ID Numbers: CR017695, 28431754DIA1030
Study First Received: January 20, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Pharmacokinetics
Pharmacodynamics
Canagliflozin

ClinicalTrials.gov processed this record on May 23, 2013