A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01286103
First received: January 13, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers


Condition Intervention Phase
Healthy
Drug: Canagliflozin 300 mg once daily and 150 mg twice daily
Drug: Canagliflozin 100 mg once daily and 50 mg twice daily
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Plasma concentrations of canagliflozin [ Time Frame: Up to Day 5 after the last treatment ] [ Designated as safety issue: No ]
  • Plasma concentrations of glucose [ Time Frame: Up to Day 5 after the last treatment ] [ Designated as safety issue: No ]
  • Urinary glucose excretion (UGE) [ Time Frame: Up to Day 5 after the last treatment ] [ Designated as safety issue: No ]
  • Renal threshold of glucose (RTG) [ Time Frame: Up to Day 5 after the last treatment ] [ 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 8) ] [ Designated as safety issue: No ]
  • Changes in hematology laboratory parameters [ Time Frame: Up to 10 days after last dose (last dose is given on Day 8) ] [ Designated as safety issue: No ]
  • Changes in chemistry laboratory parameters [ Time Frame: Up to 10 days after last dose (last dose is given on Day 8) ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2011
Study Completion Date: May 2011
Arms Assigned Interventions
Experimental: 001
Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
Drug: Canagliflozin 300 mg once daily and 150 mg twice daily
Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
Experimental: 002
Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
Drug: Canagliflozin 100 mg once daily and 50 mg twice daily
Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.

Detailed Description:

This is an open-label (volunteers will know the names of treatments they are 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). Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth [PO] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.

  Eligibility

Ages Eligible for Study:   18 Years to 45 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 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: NCT01286103

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: Director, Clinical Pharmacology Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01286103     History of Changes
Other Study ID Numbers: CR017824, 28431754DIA1032
Study First Received: January 13, 2011
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 21, 2014