Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Canagliflozin 300 mg; Drug: Placebo; Drug: Somatostatin; Drug: C-peptide

• Registration Number: NCT01665638
• Lead Sponsor: Janssen-Cilag International NV

Brief 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.

Detailed Description

This is a double-blind (neither the volunteer nor the study doctor/staff will know the identity of the assigned treatments) study to assess the effect of single oral (taken by mouth) dose of canagliflozin on clearance (removal from the body) of C-peptide in healthy adult volunteers. Healthy volunteers will be randomly (by chance) assigned to receive a single oral dose of canagliflozin followed by a single oral dose of placebo (inactive substance) or a single dose of placebo followed by a single dose of canagliflozin with a period of 7-10 days between treatments. Healthy volunteers will also receive intravenous (i.v.) infusion (injection in the vein) of somatostatin for 4 hours and a single dose i.v. injection of synthetic human C-peptide following administration of canagliflozin or placebo during each treatment period. Somatostatin will suppress the normal secretion of C-peptide, a protein that is released from the pancreas during insulin secretion, so that the human C-peptide administered to volunteers can be accurately measured. The total study duration for each volunteer will be approximately 44 days. During the study, blood and urine samples will be drawn (collected) for clinical laboratory evaluations.

Study Timeline

• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Study Start: 2012-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence Group AB	Canagliflozin 300 mg	-
Treatment Sequence Group AB	Placebo	-
Treatment Sequence Group BA	Placebo	-
Treatment Sequence Group BA	Canagliflozin 300 mg	-
Treatment Sequence Group BA	C-peptide	-
Treatment Sequence Group AB	C-peptide	-
Treatment Sequence Group AB	Somatostatin	-
Treatment Sequence Group BA	Somatostatin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in C-peptide kinetic parameters	Before and after study drug administration on Day 1 of Treatment Periods 1 and 2	Parameters are volume of distribution (Vd), clearance (CL) and half life (T1/2)

Secondary Outcome Measures

Name	Time	Method
The number of volunteers who report adverse events	Up to 22 days following Day 1 of Treatment Period 1