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

NCT ID: NCT01748526

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-09-30

Brief 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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Each volunteer will receive a single 200 mg dose of canagliflozin (JNJ-28431754) on Day 1.

Group Type: EXPERIMENTAL

Canagliflozin (JNJ-28431754) 200 mg

Intervention Type: DRUG

One 200 mg tablet taken orally (by mouth) on Day 1.

Treatment B

Each volunteer will receive a single 300 mg dose of canagliflozin (JNJ-28431754) on Day 1.

Group Type: EXPERIMENTAL

Canagliflozin (JNJ-28431754) 300 mg

Intervention Type: DRUG

One 300 mg tablet taken orally (by mouth) on Day 1.

Interventions

Canagliflozin (JNJ-28431754) 200 mg

One 200 mg tablet taken orally (by mouth) on Day 1.

Intervention Type: DRUG

Canagliflozin (JNJ-28431754) 300 mg

One 300 mg tablet taken orally (by mouth) on Day 1.

Intervention Type: DRUG

Other Intervention Names

JNJ-28431754; JNJ-28431754

Eligibility 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

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

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Ahmedabad, , India

Countries

India

References

Devineni D, Polidori D, Curtin C, Stieltjes H, Tian H, Wajs E. Single-dose Pharmacokinetics and Pharmacodynamics of Canagliflozin, a Selective Inhibitor of Sodium Glucose Cotransporter 2, in Healthy Indian Participants. Clin Ther. 2016 Jan 1;38(1):89-98.e1. doi: 10.1016/j.clinthera.2015.11.008. Epub 2015 Dec 11.

Reference Type: DERIVED

PMID: 26687552 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=2204&filename=CR014986_CSR.pdf

A Single-Dose, Open-Label, Randomized, Two-Way, Cross-Over Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Healthy Indian Subjects

Other Identifiers

28431754DIA1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR014986

Identifier Type: -

Identifier Source: org_study_id