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

Condition(s) targeted: Healthy

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

Phase: Phase 1

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Official title: An Open-Label Drug-Drug Interaction Study in Healthy Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of Glyburide

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Plasma concentrations of glyburide

Plasma concentrations of glyburide metabolites

Secondary outcome:

Change from baseline in plasma glucose concentrations

Change from baseline in plasma insulin concentrations

Change from baseline in plasma C-peptide concentrations

Detailed description: This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days) to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and pharmacodynamics of glyburide (a blood glucose-lowering agent used to treat patients with diabetes). The study will consist of 3 phases; a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each volunteer will receive a single 1. 25 mg dose of glyburide on Day 1, followed by 200 mg canagliflozin once daily on Days 4 through 8. On Day 9 volunteers will receive both glyburide 1. 25 mg and canagliflozin 200 mg. Each volunteer will participate in the study for approximately 40 days.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Volunteer must have a body mass index (BMI = weight in kg/height in m2) between 18

and 30 kg/m2 (inclusive) and body weight not less than 50 kg Exclusion Criteria:

- 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

Starting date: July 2008
Last updated: December 11, 2012