Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

NCT01665638 | Completed Phase 1

• 3 other identifiers: CR10080028431754DIA10492012-001667-73
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Clearance; Canagliflozin; JNJ-28431754; Placebo; Somatostatin; C-peptide

Outcome Measures

Primary Outcomes (1)

• Change from baseline in C-peptide kinetic parameters

  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 Outcomes (1)

• The number of volunteers who report adverse events

  Up to 22 days following Day 1 of Treatment Period 1

Study Arms (2)

Treatment Sequence Group AB

EXPERIMENTAL

Drug: Canagliflozin 300 mg; Drug: Placebo; Drug: Somatostatin; Drug: C-peptide

Treatment Sequence Group BA

EXPERIMENTAL

Drug: Canagliflozin 300 mg; Drug: Placebo; Drug: Somatostatin; Drug: C-peptide

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.

Treatment Sequence Group AB; Treatment Sequence Group BA

Placebo DRUG

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

Treatment Sequence Group AB; Treatment Sequence Group BA

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.

Treatment Sequence Group AB; Treatment Sequence Group BA

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.

Treatment Sequence Group AB; Treatment Sequence Group BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

MeSH Terms

Interventions

Canagliflozin; Somatostatin; C-Peptide

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Proinsulin; Insulins

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

DE (1)