Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether treatment with a single oral 300 mg dose of canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a protein released from the pancreas during insulin secretion) in healthy adult volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Canagliflozin; Somatostatin

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 or clinically significant adverse reactions to canagliflozin or placebo or any of the excipients of the canagliflozin or placebo formulation

• Known hypersensitivity of synthetic human C-peptide, somatostatin preparation, or other structurally related peptides