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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Canagliflozin (JNJ-28431754) 300 mg

Drug: Canagliflozin (JNJ-28431754) 200 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01748526

CR014986

28431754DIA1008 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), randomized (the treatment is assigned by chance), single center, single dose, 2-way cross-over study (all volunteers switch from one treatment to another) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in healthy Indian volunteers. The study will consist of 3 phases: a single screening phase, a baseline phase of 2 days per period, and an open-label treatment phase that includes 2 treatment periods (Periods 1 and 2). During Period 1, volunteers will be randomly assigned to receive a single dose of either 200 mg (Treatment A) or 300 mg (Treatment B) of canagliflozin on Day 1. During Period 2, volunteers will receive the dose of canagliflozin (Treatment A or B) that they did not receive during Period 1. The duration of each treatment period will be 4 days and each treatment period will be separated by a 14 day washout period (when no medication is given). Each volunteer will participate in the study for approximately 45 days.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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