Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

Sponsor
Janssen-Cilag International NV
Study ID
NCT01665638
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin 300 mg — DRUG
    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.
  • Placebo — DRUG
    Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
  • Somatostatin — DRUG
    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.
  • C-peptide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2012
Status verified
Jun 2013
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: Treatment Sequence Group AB
  • Experimental: Treatment Sequence Group BA

Primary Outcome Measure

Change from baseline in C-peptide kinetic parameters [ Time Frame: Before and after study drug administration on Day 1 of Treatment Periods 1 and 2 ]

Related Studies