A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Treatment C: Placebo

Drug: Treatment A: Canagliflozin 100 mg

Drug: Treatment B: Canagliflozin 300 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01707316

CR100923

28431754DIA1026 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.

Full description

This study will be a double-blind (neither the Investigator nor volunteer knows the assigned treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the study treatments is inactive), single-dose, 3-way cross over study (all volunteers will receive each of the 3 treatments but in a different order) in healthy Chinese volunteers. Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The treatment sequence will be decided by randomization. Treatment A will be a single oral (by mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each treatment will be given during a treatment period of 5 days duration; each treatment period will be separated by a washout period (a time period with no medication) of at least 10 days. Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus (T2DM).

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Volunteers must be non-smokers for at least 6 months before first study drug administration
Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

15 participants in 3 patient groups

Sequence 1: Treatment A-B-C

Experimental group

Description:

The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.

Treatment:

Drug: Treatment B: Canagliflozin 300 mg

Other: Treatment C: Placebo

Drug: Treatment A: Canagliflozin 100 mg

Sequence 2: Treatment B-C-A

Experimental group

Description:

Treatment:

Drug: Treatment B: Canagliflozin 300 mg

Other: Treatment C: Placebo

Drug: Treatment A: Canagliflozin 100 mg

Sequence 3: Treatment C-A-B