Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Healthy
Interventions
DRUG

Canagliflozin 300 mg

Singe over-encapsulated 300 mg tablet of canagliflozin administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.

DRUG

Placebo

Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.

DRUG

Somatostatin

A primed (50 mcg in 1 mL sterile 0.9% NaCl solution i.v. injection over 1 minute) constant (500 mcg/hour) i.v. infusion of somatostatin for 4 hours approximately 2 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2. The total dose of somatostatin administered during each period will be 50 mcg + 500 mcg/hour x 4 hours = 2050 mcg.

DRUG

C-peptide

Single bolus dose of 150 mcg synthetic human C-peptide in 1 mL water for injection administered i.v. (in the vein) approximately 3 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2.

Trial Locations (1)

Unknown

Neuss

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY