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

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:

Drug Information available for: Canagliflozin

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: 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 May 16, 2013