A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of canagliflozin (JNJ-28431754) in healthy Indian volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg

• Volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 mL/min/1.73 m2 using the Modification of Diet in Renal Disease calculation

• Fasting blood glucose at screening must be less than 100 mg/dL and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dL

Exclusion Criteria:

• 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

• Female volunteer is breast-feeding

• Volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months