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

NCT ID: NCT01707316

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-08-31

Brief Summary

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.

Detailed 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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1: Treatment A-B-C

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.

Group Type: EXPERIMENTAL

Treatment A: Canagliflozin 100 mg

Intervention Type: DRUG

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

Treatment B: Canagliflozin 300 mg

Intervention Type: DRUG

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

Treatment C: Placebo

Intervention Type: OTHER

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Sequence 2: Treatment B-C-A

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.

Group Type: EXPERIMENTAL

Treatment A: Canagliflozin 100 mg

Intervention Type: DRUG

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

Treatment B: Canagliflozin 300 mg

Intervention Type: DRUG

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

Treatment C: Placebo

Intervention Type: OTHER

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Sequence 3: Treatment C-A-B

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.

Group Type: EXPERIMENTAL

Treatment A: Canagliflozin 100 mg

Intervention Type: DRUG

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

Treatment B: Canagliflozin 300 mg

Intervention Type: DRUG

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

Treatment C: Placebo

Intervention Type: OTHER

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Interventions

Treatment A: Canagliflozin 100 mg

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

Intervention Type: DRUG

Treatment B: Canagliflozin 300 mg

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

Intervention Type: DRUG

Treatment C: Placebo

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Intervention Type: OTHER

Other Intervention Names

JNJ-28431754; JNJ-28431754

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Beijing, , China

Countries

China

References

Chen X, Hu P, Vaccaro N, Polidori D, Curtin CR, Stieltjes H, Sha S, Weiner S, Devineni D. Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects. Clin Ther. 2015 Jul 1;37(7):1483-1492.e1. doi: 10.1016/j.clinthera.2015.04.015. Epub 2015 Jun 3.

Reference Type: DERIVED

PMID: 26048186 (View on PubMed)

Other Identifiers

28431754DIA1026

Identifier Type: OTHER

Identifier Source: secondary_id

CR100923

Identifier Type: -

Identifier Source: org_study_id