- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665638
Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers
June 6, 2013 updated by: Janssen-Cilag International NV
A Double-Blind, Randomized, Placebo-Controlled, 2-Way Cross-Over Study to Evaluate the Effect of Single Dose Canagliflozin on Kinetics of C-Peptide in Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Neuss, Germany
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence Group AB
|
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.
Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
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.
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.
|
Experimental: Treatment Sequence Group BA
|
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.
Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Parameters are volume of distribution (Vd), clearance (CL) and half life (T1/2)
|
Before and after study drug administration on Day 1 of Treatment Periods 1 and 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of volunteers who report adverse events
Time Frame: Up to 22 days following Day 1 of Treatment Period 1
|
Up to 22 days following Day 1 of Treatment Period 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
August 13, 2012
First Submitted That Met QC Criteria
August 13, 2012
First Posted (Estimate)
August 15, 2012
Study Record Updates
Last Update Posted (Estimate)
June 7, 2013
Last Update Submitted That Met QC Criteria
June 6, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100800
- 28431754DIA1049 (Other Identifier: Janssen-Cilag International NV)
- 2012-001667-73 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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