A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers

NCT01733108 | Completed Phase 1

• 2 other identifiers: CR01487228431754DIA1004
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of glyburide.

Conditions

Healthy

Keywords

Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Glyburide (MICRONASE)

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of glyburide

  Comparison of plasma concentrations of glyburide following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.

  Up to Day 12

• Plasma concentrations of glyburide metabolites

  Comparison of plasma concentrations of glyburide metabolites following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.

  Up to Day 12

Secondary Outcomes (3)

• Change from baseline in plasma glucose concentrations

  Day -1 (Baseline) up to Day 9

• Change from baseline in plasma insulin concentrations

  Day -1 (Baseline) up to Day 9

• Change from baseline in plasma C-peptide concentrations

  Day -1 (Baseline) up to Day 9

Study Arms (1)

Canagliflozin (JNJ-28431754) + glyburide

EXPERIMENTAL

Each volunteer will receive a single dose of glyburide on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of glyburide in combination with a single dose of canagliflozin.

Drug: Glyburide; Drug: Canagliflozin (JNJ-28431754)

Interventions

Glyburide DRUG

One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.

Also known as: Micronase

Canagliflozin (JNJ-28431754) + glyburide

Canagliflozin (JNJ-28431754) DRUG

One 200 mg tablet taken orally (by mouth) on Days 4 through 9.

Also known as: JNJ-28431754

Canagliflozin (JNJ-28431754) + glyburide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Volunteer has a history of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
• Volunteer has a fasting plasma glucose \< 100 mg/dL (as measured by oral glucose tolerance test) and a 2-hour plasma glucose \<= 140 mg/dL
• History of smoking or use of nicotine-containing substances within the previous 6 months

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Devineni D, Manitpisitkul P, Murphy J, Skee D, Wajs E, Mamidi RN, Tian H, Vandebosch A, Wang SS, Verhaeghe T, Stieltjes H, Usiskin K. Effect of canagliflozin on the pharmacokinetics of glyburide, metformin, and simvastatin in healthy participants. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):226-36. doi: 10.1002/cpdd.166. Epub 2014 Oct 27.

  PMID: 27140803 DERIVED

MeSH Terms

Interventions

Glyburide; Canagliflozin

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Thiophenes; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 12, 2012

Record last verified: 2012-12